[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-jiangsu-shenli-medical-production-co-ltd-677753-03182024":3,"fda-latest-sync-dates":28},{"id":4,"letter_id":5,"action_type":6,"firm_name":7,"fei_number":8,"issuing_office":9,"subject":10,"posted_date":11,"action_taken_date":12,"response_letter_date":8,"closeout_date":8,"case_status":13,"letter_url":14,"reference_number":8,"marcs_cms_no":15,"product_type":16,"delivery_method":8,"recipient_name":17,"recipient_title":8,"body_html":18,"body_text":19,"body_fetched_at":20,"medical_device_id":8,"raw":21,"created_at":26,"updated_at":27},1557,"jiangsu-shenli-medical-production-co-ltd-677753-03182024","Warning Letter","Jiangsu Shenli Medical Production Co., Ltd.",null,"Center for Devices and Radiological Health","CGMP\u002FQSR\u002FMedical Devices\u002FPMA\u002FAdulterated\u002FMisbranded","2024-03-19","2024-03-18","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fjiangsu-shenli-medical-production-co-ltd-677753-03182024","677753","Medical Devices","Liqun Yang","\n\n                            \n                            \n                            \n                            \n                                              \n  \n \n\n                 \n\n \n\n\u003Cdiv class=\"inset-column\">\n  \u003Cdl class=\"lcds-description-list--grid\">\n\n      \n      \n              \u003Cdt class=\"cell-1_3\">Product:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_3\">Medical Devices                          \n            \n            \n            \n            \n            \n            \n            \n             \n            \n            \n            \n              \n            \n            \n            \u003C\u002Fdd>\n      \n          \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n\n\u003Chr>\n\n\u003Cdiv class=\"row inset-column\">\n  \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n\n        \u003Cdt>Recipient:\u003C\u002Fdt>\n\n                      \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-name field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Name\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">Liqun Yang\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                                \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-title field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Title\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">General Manager\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Jiangsu Shenli Medical Production Co., Ltd.\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">No. 20 Changzheng Road\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"address-line2\">Zhengluzhen\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"dependent-locality\">Wujin Qu\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Changzhou Shi\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"administrative-area\">Jiangsu Sheng\u003C\u002Fspan>,\u003Cbr>\n\u003Cspan class=\"country\">China\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \n          \n            \n            \u003Cdd>\u003C!-- Loop this field. For FDA Office content type. Display the Other contact channel is a dd span with an icon-->\n\n    \u003C\u002Fdd>\u003Cdd>\u003Cspan class=\"fa fa-envelope\" aria-hidden=\"true\">\u003C\u002Fspan>\u003Ca href=\"mailto:(b)(4)\"> (b)(4)\u003C\u002Fa>\u003C\u002Fdd>\n\n          \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n       \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n          \n          \u003Cdt>Issuing Office:\u003C\u002Fdt>\n        \n         \n          \u003Cdd>Center for Devices and Radiological Health\u003C\u002Fdd>\n        \n         \n          \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n        \n        \n        \n        \n        \n    \u003C\u002Fdl>\n    \u003Cdl class=\"\"> \n      \n  \u003Cdiv class=\"field field--name-field-issuing-office-paragraph field--type-entity-reference-revisions field--label-above\">\n    \u003Cdiv class=\"field--label\">Secondary Issuing Offices\u003C\u002Fdiv>\n          \u003Cdiv class=\"field--items\">\n              \u003Cdiv class=\"field--item\">    \u003Cbr>\n    \n     \n        \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n    \n    \n    \n    \n\u003C\u002Fdiv>\n              \u003C\u002Fdiv>\n      \u003C\u002Fdiv>\n\n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>  \n      \n\u003C\u002Fdiv>\n\n \n\n \n\n\u003Chr>\n\n\u003Cp class=\"text-align-center\">\u003Cstrong>WARNING LETTER \u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp class=\"text-align-center\">\u003Cstrong>CMS # 677753\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>March 11, 2024\u003C\u002Fp>\n\n\u003Cp>Dear Mr. Yang,\u003C\u002Fp>\n\n\u003Cp>The United States Food and Drug Administration (FDA) has learned that your firm is marketing Jiangsu Shenli Medical Production Co. Ltd. piston syringes of the sizes and configurations listed in Table 1 below in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).\u003C\u002Fp>\n\n\u003Ctable class=\"MsoTableGrid\" style=\"border-collapse: collapse; border: none; width: 780px;\">\n\t\u003Ctbody>\n\t\t\u003Ctr>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:1px solid black; border-right:1px solid black; border-left:1px solid black\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cstrong>Model #\u003C\u002Fstrong>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 173px; padding: 0in 7px; border-top: 1px solid black; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cstrong>Item Description\u003C\u002Fstrong>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 139px; padding: 0in 7px; border-top: 1px solid black; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cstrong>Model #\u003C\u002Fstrong>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 251px; padding: 0in 7px; border-top: 1px solid black; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>\u003Cstrong>Item Description\u003C\u002Fstrong>\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\u003C\u002Ftr>\n\t\t\u003Ctr>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:1px solid black\" valign=\"top\">\n\t\t\t\u003Cp>83077\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 173px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 30ML L\u002FS\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 139px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>91839\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 251px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 20ML L\u002FL YELLOW\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\u003C\u002Ftr>\n\t\t\u003Ctr>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:1px solid black\" valign=\"top\">\n\t\t\t\u003Cp>83078\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 173px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 30ML L\u002FL\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 139px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>91840\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 251px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 3ML L\u002FL PURPLE\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\u003C\u002Ftr>\n\t\t\u003Ctr>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:1px solid black\" valign=\"top\">\n\t\t\t\u003Cp>83079\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 173px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 60ML L\u002FS\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 139px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>91841\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 251px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 5ML L\u002FL PURPLE\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\u003C\u002Ftr>\n\t\t\u003Ctr>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:1px solid black\" valign=\"top\">\n\t\t\t\u003Cp>83080\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 173px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 60ML L\u002FL\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 139px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>91842\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 251px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 10ML L\u002FL PURPLE\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\u003C\u002Ftr>\n\t\t\u003Ctr>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:1px solid black\" valign=\"top\">\n\t\t\t\u003Cp>83081\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 173px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 10ML L\u002FS\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 139px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>91845\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 251px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 20ML L\u002FL BLUE SALINE\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\u003C\u002Ftr>\n\t\t\u003Ctr>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:1px solid black\" valign=\"top\">\n\t\t\t\u003Cp>83082\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 173px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 10ML L\u002FL\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 139px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>91846\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 251px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 10ML L\u002FL YELLOW CONT\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\u003C\u002Ftr>\n\t\t\u003Ctr>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:1px solid black\" valign=\"top\">\n\t\t\t\u003Cp>83083\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 173px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 3ML L\u002FS\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 139px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>91847\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 251px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 10ML L\u002FL BLUE LIDO\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\u003C\u002Ftr>\n\t\t\u003Ctr>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:1px solid black\" valign=\"top\">\n\t\t\t\u003Cp>83084\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 173px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 3ML L\u002FL\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 139px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>91849\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 251px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 10ML L\u002FL BLUE SALINE\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\u003C\u002Ftr>\n\t\t\u003Ctr>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:1px solid black\" valign=\"top\">\n\t\t\t\u003Cp>83085\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 173px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 5ML L\u002FS\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 139px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>91850\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 251px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 10ML L\u002FL RED LIDO\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\u003C\u002Ftr>\n\t\t\u003Ctr>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:1px solid black\" valign=\"top\">\n\t\t\t\u003Cp>83087\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 173px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 20ML L\u002FS\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 139px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>91851\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 251px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 10ML L\u002FL RED HEPARIN\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\u003C\u002Ftr>\n\t\t\u003Ctr>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:1px solid black\" valign=\"top\">\n\t\t\t\u003Cp>83088\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 173px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 20ML L\u002FL\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 139px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>91852\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 251px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 5ML L\u002FL YELLOW NITRO\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\u003C\u002Ftr>\n\t\t\u003Ctr>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:1px solid black\" valign=\"top\">\n\t\t\t\u003Cp>83089\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 173px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 1ML TB\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 139px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>91854\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 251px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 10ML L\u002FL YELLOW LIDO\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\u003C\u002Ftr>\n\t\t\u003Ctr>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:1px solid black\" valign=\"top\">\n\t\t\t\u003Cp>91820\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 173px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 3ML L\u002FL RED\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 139px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>91855\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 251px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 10ML L\u002FL YELLOW HEP\u002FSALINE\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\u003C\u002Ftr>\n\t\t\u003Ctr>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:1px solid black\" valign=\"top\">\n\t\t\t\u003Cp>91821\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 173px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 3ML L\u002FL GREEN\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 139px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>91856\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 251px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 10ML L\u002FL RED CONT\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\u003C\u002Ftr>\n\t\t\u003Ctr>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:1px solid black\" valign=\"top\">\n\t\t\t\u003Cp>91822\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 173px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 3ML L\u002FL BLUE\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 139px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>91857\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 251px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 10ML L\u002FL GREEN CONT\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\u003C\u002Ftr>\n\t\t\u003Ctr>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:1px solid black\" valign=\"top\">\n\t\t\t\u003Cp>91825\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 173px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 5ML L\u002FL RED\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 139px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>91858\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 251px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 20ML L\u002FL WHITE SALINE\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\u003C\u002Ftr>\n\t\t\u003Ctr>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:1px solid black\" valign=\"top\">\n\t\t\t\u003Cp>91826\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 173px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 5ML L\u002FL GREEN\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 139px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>91859\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 251px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 5ML L\u002FL PURPLE NITRO\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\u003C\u002Ftr>\n\t\t\u003Ctr>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:1px solid black\" valign=\"top\">\n\t\t\t\u003Cp>91827\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 173px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 5ML L\u002FL BLUE\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 139px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>91863\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 251px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 20ML L\u002FL YELLOW LIDO\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\u003C\u002Ftr>\n\t\t\u003Ctr>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:1px solid black\" valign=\"top\">\n\t\t\t\u003Cp>91828\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 173px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 5ML L\u002FL WHITE\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 139px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>91866\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 251px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 5ML L\u002FL RED NITRO\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\u003C\u002Ftr>\n\t\t\u003Ctr>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:1px solid black\" valign=\"top\">\n\t\t\t\u003Cp>91829\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 173px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 5ML L\u002FL YELLOW\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 139px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>91867\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 251px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 5ML L\u002FL BLUE HEPARIN\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\u003C\u002Ftr>\n\t\t\u003Ctr>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:1px solid black\" valign=\"top\">\n\t\t\t\u003Cp>91830\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 173px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 10ML L\u002FL RED\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 139px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>91872\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 251px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 10ML L\u002FS BLUE\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\u003C\u002Ftr>\n\t\t\u003Ctr>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:1px solid black\" valign=\"top\">\n\t\t\t\u003Cp>91831\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 173px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 10ML L\u002FL GREEN\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 139px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>91873\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 251px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 10ML L\u002FL WHITE LIDO\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\u003C\u002Ftr>\n\t\t\u003Ctr>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:1px solid black\" valign=\"top\">\n\t\t\t\u003Cp>91832\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 173px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 10ML L\u002FL BLUE\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 139px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>91874\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 251px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 10ML L\u002FS RED\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\u003C\u002Ftr>\n\t\t\u003Ctr>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:1px solid black\" valign=\"top\">\n\t\t\t\u003Cp>91833\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 173px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 10ML L\u002FL WHITE\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 139px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>91876\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 251px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR CNTRL 10ML L\u002FL YEL 1\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\u003C\u002Ftr>\n\t\t\u003Ctr>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:1px solid black\" valign=\"top\">\n\t\t\t\u003Cp>91834\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 173px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 10ML L\u002FL YELLOW\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 139px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>91877\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 251px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR CNTRL 10ML L\u002FIL YELLOW LIDO\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\u003C\u002Ftr>\n\t\t\u003Ctr>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:1px solid black\" valign=\"top\">\n\t\t\t\u003Cp>91835\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 173px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 20ML L\u002FL RED\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 139px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>91878\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 251px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR CNTRL 10 ML L\u002FL RED\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\u003C\u002Ftr>\n\t\t\u003Ctr>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:1px solid black\" valign=\"top\">\n\t\t\t\u003Cp>91836\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 173px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 20ML L\u002FL GREEN\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 139px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>91879\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 251px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR CNTRL 10ML L\u002FL GRN\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\u003C\u002Ftr>\n\t\t\u003Ctr>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:1px solid black\" valign=\"top\">\n\t\t\t\u003Cp>91837\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 173px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 20ML L\u002FL BLUE\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 139px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>91880\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 251px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR CNTRL 10ML L\u002FL BLUE\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\u003C\u002Ftr>\n\t\t\u003Ctr>\n\t\t\t\u003Ctd style=\"border-bottom:1px solid black; width:156px; padding:0in 7px 0in 7px; border-top:none; border-right:1px solid black; border-left:1px solid black\" valign=\"top\">\n\t\t\t\u003Cp>91838\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 173px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 20ML L\u002FL WHITE\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 139px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>91881\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\t\u003Ctd style=\"border-bottom: 1px solid black; width: 251px; padding: 0in 7px; border-top: none; border-right: 1px solid black; border-left: none;\" valign=\"top\">\n\t\t\t\u003Cp>SYR 10ML L\u002FL CONTROL\u003C\u002Fp>\n\t\t\t\u003C\u002Ftd>\n\t\t\u003C\u002Ftr>\n\t\u003C\u002Ftbody>\n\u003C\u002Ftable>\n\n\u003Cp>\u003Cstrong>Table 1.\u003C\u002Fstrong> List of Jiangsu Shenli Medical Production Co. Ltd. piston syringe configurations implicated in this Warning Letter.\u003C\u002Fp>\n\n\u003Cp>Under section 201(h) of the Act, 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.\u003C\u002Fp>\n\n\u003Cp>FDA has determined, based on information provided by your firm and information available on the Agency's public databases, that the Jiangsu Shenli Medical Production Co. Ltd. piston syringes configurations listed in \u003Cstrong>Table 1\u003C\u002Fstrong> are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(0(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). The devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution these devices with (1) major changes or modifications to the intended use, and\u002For (2) a change or modification in the device that could significantly affect the safety or effectiveness of the device without submitting a premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(i)-(ii).\u003C\u002Fp>\n\n\u003Cp>Specifically, the Jiangsu Shenli Medical Production Co. Ltd. Piston Syringe (5cc Luer Lock) was cleared under K103830 with the following indications for use: The intended use of the Jiangsu Shenli Medical Production Co., Ltd. 5cc luer lock piston syringe is to inject fluids into or withdraw fluids from the body. Based on FDA's evaluation of your firm's activities, there is evidence that your firm is engaged in the distribution of syringes for use within the United States with substantially different technological characteristics, namely sizes other than 5 mL, luer slip instead of luer lock tips, syringes intended for specific drugs, different colors (i.e., colorants), and control syringes, each of which constitute a significant change or modification in design that could significantly alter the safety or effectiveness of the device. For further explanation on the need for a new premarket notification, or \"510(k),\" for changes to the intended use or design affecting safety and effectiveness, it is recommended you consult the guidance document \"Deciding When to Submit a 510(k) for a Change to an Existing Device — Guidance for Industry and Food and Drug Administration Staff (fda.gov).\" In the guidance at Figure 3 — Flowchart B: Technology, Engineering, and Performance Changes, FDA explains why changes in size, color, specific drug indications and connector type all constitute a major change or modification to the device's intended use, for which your firm lacks clearance or approval.\u003C\u002Fp>\n\n\u003Cp>As discussed above the products listed in \u003Cstrong>Table 1\u003C\u002Fstrong> are misbranded because you made one or more change(s) or modification(s) to each device that could significantly affect the safety or effectiveness of the device without submitting a 510(k) to FDA. Specifically, changing the volume of the syringe, switching from a luer lock to a luer slip syringe tip, and changing from a traditional syringe to a control syringe could result in the risk of patient harm such as inaccurate dosing, a leaking device, a higher risk of inappropriate needle detachment, and incorrect device handling. Furthermore, the addition of color additives to your syringe could result in adverse health effects such as allergic reactions, skin irritation or inflammation, pain, fever, red blood cell damage that induces organ stress, and toxicity that leads to loss of organ function or failure. Labeling the syringe for a specific drug can also cause harm because differences in drug viscosities impact the function of the syringe and can result in patient harm such as inaccurate dosing or incorrect drug usage.\u003C\u002Fp>\n\n\u003Cp>Your firm's failure to submit 510(k)s for these devices has prevented FDA from evaluating the risks posed by these substantially different technological characteristics or from determining that there is reasonable assurance of the safety and effectiveness of these modified devices such that they may be legally marketed syringes. Further, FDA has observed evidence of postmarket safety signals indicating product quality issues that have the potential to cause serious patient harm. Specifically, FDA is aware of multiple customer complaints regarding quality issues (e.g. cracks, breakage during use) for syringes in surgical kits supplied by Jiangsu Shenli Medical Production Co. Ltd.\u003C\u002Fp>\n\n\u003Cp>For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http:\u002F\u002Fwww.fda.gov\u002FMedicalDevices\u002FDeviceRegulationandGuidance\u002FHowtoMarketYourDevice\u002Fdefault.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.\u003C\u002Fp>\n\n\u003Cp>FDA requests that Jiangsu Shenli Medical Production Factory cease any activities that result in the misbranding or adulteration of all the Jiangsu Shenli Medical Production Co. Ltd. piston syringe configurations listed in \u003Cstrong>Table 1\u003C\u002Fstrong>, such as the commercial distribution of the device sizes, configurations, and uses discussed above, including selling to initial importers, distributors, or other third parties for distribution and use within the United States or otherwise representing these devices to have the requisite clearance or authorization for marketing in the United States.\u003C\u002Fp>\n\n\u003Cp>Given the serious nature of the violations of the Act and growing evidence of potential harm, all the Jiangsu Shenli Medical Production Co. Ltd. piston syringes configurations listed in \u003Cstrong>Table 1\u003C\u002Fstrong> are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated. As a result, FDA is taking steps to refuse entry of these devices into the United States, until these violations are addressed.\u003C\u002Fp>\n\n\u003Cp>Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and\u002For corrective actions (which must address systemic problems) your firm has taken. If your firm's planned corrections and\u002For corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and\u002For corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm's response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration as part of your response.\u003C\u002Fp>\n\n\u003Cp>Your firm's response should be sent by email to CDRHWamingLetterResponses@fda.hhs.gov or by mail to:\u003C\u002Fp>\n\n\u003Cp>Food and Drug Administration\u003Cbr>\nCenter for Devices and Radiological Health\u003Cbr>\nOffice of Regulatory Programs\u003Cbr>\nDivision of Regulatory Programs 2: Establishment Support\u003Cbr>\nRegulatory Inspections and Audits Team\u003Cbr>\nWhite Oak Building 66\u003Cbr>\n10903 New Hampshire Ave.\u003Cbr>\nSilver Spring, MD 20993\u003C\u002Fp>\n\n\u003Cp>Refer to the identification number \u003Cstrong>CMS # 677753\u003C\u002Fstrong> when replying. We remind you that only written communication is considered as official. If you have any questions about the contents of this letter, please contact: Shruti Misty at Shruti.Mistry@fda.hhs.gov.\u003C\u002Fp>\n\n\u003Cp>Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm. It is your firm's responsibility to ensure compliance with the applicable laws and regulations administered by FDA.\u003C\u002Fp>\n\n\u003Cp>Sincerely yours,\u003Cbr>\n\u002FS\u002F\u003C\u002Fp>\n\n\u003Cp>Kellie B. Kelm, Ph.D.\u003Cbr>\nActing Director\u003Cbr>\nOHT3: Office of GastroRenal, ObGyn,\u003Cbr>\nGeneral Hospital and Urology Devices\u003Cbr>\nOffice of Product Evaluation and Quality\u003Cbr>\nCenter for Devices and Radiological Health\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>Cc:\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>Official correspondent:\u003C\u002Fstrong>\u003Cbr>\nCai Xiaotian at \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>US Agent:\u003C\u002Fstrong>\u003Cbr>\nCharles Mack\u003Cbr>\nIRC USA\u003Cbr>\n2950 E Lindrick Dr\u003Cbr>\nChandler, AZ, US 85249\u003Cbr>\nEmail: \u003Cstrong>(b)(4)\u003C\u002Fstrong> or&nbsp;\u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fp>\n\n\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\n\n\n              \n                                            \n              \n            ","Product:\n\nMedical Devices\n\nRecipient:\n\nRecipient Name\n\nLiqun Yang\n\nRecipient Title\n\nGeneral Manager\n\nJiangsu Shenli Medical Production Co., Ltd.\n\nNo. 20 Changzheng Road\n\nZhengluzhen\n\nWujin Qu\n\nChangzhou Shi\n\nJiangsu Sheng,\n\nChina\n\n(b)(4)\n\nIssuing Office:\n\nCenter for Devices and Radiological Health\n\nUnited States\n\nSecondary Issuing Offices\n\nUnited States\n\nWARNING LETTER\n\nCMS # 677753\n\nMarch 11, 2024\n\nDear Mr. Yang,\n\nThe United States Food and Drug Administration (FDA) has learned that your firm is marketing Jiangsu Shenli Medical Production Co. Ltd. piston syringes of the sizes and configurations listed in Table 1 below in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).\n\nModel #\n\nItem Description\n\nModel #\n\nItem Description\n\n83077\n\nSYR 30ML L\u002FS\n\n91839\n\nSYR 20ML L\u002FL YELLOW\n\n83078\n\nSYR 30ML L\u002FL\n\n91840\n\nSYR 3ML L\u002FL PURPLE\n\n83079\n\nSYR 60ML L\u002FS\n\n91841\n\nSYR 5ML L\u002FL PURPLE\n\n83080\n\nSYR 60ML L\u002FL\n\n91842\n\nSYR 10ML L\u002FL PURPLE\n\n83081\n\nSYR 10ML L\u002FS\n\n91845\n\nSYR 20ML L\u002FL BLUE SALINE\n\n83082\n\nSYR 10ML L\u002FL\n\n91846\n\nSYR 10ML L\u002FL YELLOW CONT\n\n83083\n\nSYR 3ML L\u002FS\n\n91847\n\nSYR 10ML L\u002FL BLUE LIDO\n\n83084\n\nSYR 3ML L\u002FL\n\n91849\n\nSYR 10ML L\u002FL BLUE SALINE\n\n83085\n\nSYR 5ML L\u002FS\n\n91850\n\nSYR 10ML L\u002FL RED LIDO\n\n83087\n\nSYR 20ML L\u002FS\n\n91851\n\nSYR 10ML L\u002FL RED HEPARIN\n\n83088\n\nSYR 20ML L\u002FL\n\n91852\n\nSYR 5ML L\u002FL YELLOW NITRO\n\n83089\n\nSYR 1ML TB\n\n91854\n\nSYR 10ML L\u002FL YELLOW LIDO\n\n91820\n\nSYR 3ML L\u002FL RED\n\n91855\n\nSYR 10ML L\u002FL YELLOW HEP\u002FSALINE\n\n91821\n\nSYR 3ML L\u002FL GREEN\n\n91856\n\nSYR 10ML L\u002FL RED CONT\n\n91822\n\nSYR 3ML L\u002FL BLUE\n\n91857\n\nSYR 10ML L\u002FL GREEN CONT\n\n91825\n\nSYR 5ML L\u002FL RED\n\n91858\n\nSYR 20ML L\u002FL WHITE SALINE\n\n91826\n\nSYR 5ML L\u002FL GREEN\n\n91859\n\nSYR 5ML L\u002FL PURPLE NITRO\n\n91827\n\nSYR 5ML L\u002FL BLUE\n\n91863\n\nSYR 20ML L\u002FL YELLOW LIDO\n\n91828\n\nSYR 5ML L\u002FL WHITE\n\n91866\n\nSYR 5ML L\u002FL RED NITRO\n\n91829\n\nSYR 5ML L\u002FL YELLOW\n\n91867\n\nSYR 5ML L\u002FL BLUE HEPARIN\n\n91830\n\nSYR 10ML L\u002FL RED\n\n91872\n\nSYR 10ML L\u002FS BLUE\n\n91831\n\nSYR 10ML L\u002FL GREEN\n\n91873\n\nSYR 10ML L\u002FL WHITE LIDO\n\n91832\n\nSYR 10ML L\u002FL BLUE\n\n91874\n\nSYR 10ML L\u002FS RED\n\n91833\n\nSYR 10ML L\u002FL WHITE\n\n91876\n\nSYR CNTRL 10ML L\u002FL YEL 1\n\n91834\n\nSYR 10ML L\u002FL YELLOW\n\n91877\n\nSYR CNTRL 10ML L\u002FIL YELLOW LIDO\n\n91835\n\nSYR 20ML L\u002FL RED\n\n91878\n\nSYR CNTRL 10 ML L\u002FL RED\n\n91836\n\nSYR 20ML L\u002FL GREEN\n\n91879\n\nSYR CNTRL 10ML L\u002FL GRN\n\n91837\n\nSYR 20ML L\u002FL BLUE\n\n91880\n\nSYR CNTRL 10ML L\u002FL BLUE\n\n91838\n\nSYR 20ML L\u002FL WHITE\n\n91881\n\nSYR 10ML L\u002FL CONTROL\n\nTable 1. List of Jiangsu Shenli Medical Production Co. Ltd. piston syringe configurations implicated in this Warning Letter.\n\nUnder section 201(h) of the Act, 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.\n\nFDA has determined, based on information provided by your firm and information available on the Agency's public databases, that the Jiangsu Shenli Medical Production Co. Ltd. piston syringes configurations listed in Table 1 are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(0(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). The devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution these devices with (1) major changes or modifications to the intended use, and\u002For (2) a change or modification in the device that could significantly affect the safety or effectiveness of the device without submitting a premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(i)-(ii).\n\nSpecifically, the Jiangsu Shenli Medical Production Co. Ltd. Piston Syringe (5cc Luer Lock) was cleared under K103830 with the following indications for use: The intended use of the Jiangsu Shenli Medical Production Co., Ltd. 5cc luer lock piston syringe is to inject fluids into or withdraw fluids from the body. Based on FDA's evaluation of your firm's activities, there is evidence that your firm is engaged in the distribution of syringes for use within the United States with substantially different technological characteristics, namely sizes other than 5 mL, luer slip instead of luer lock tips, syringes intended for specific drugs, different colors (i.e., colorants), and control syringes, each of which constitute a significant change or modification in design that could significantly alter the safety or effectiveness of the device. For further explanation on the need for a new premarket notification, or \"510(k),\" for changes to the intended use or design affecting safety and effectiveness, it is recommended you consult the guidance document \"Deciding When to Submit a 510(k) for a Change to an Existing Device — Guidance for Industry and Food and Drug Administration Staff (fda.gov).\" In the guidance at Figure 3 — Flowchart B: Technology, Engineering, and Performance Changes, FDA explains why changes in size, color, specific drug indications and connector type all constitute a major change or modification to the device's intended use, for which your firm lacks clearance or approval.\n\nAs discussed above the products listed in Table 1 are misbranded because you made one or more change(s) or modification(s) to each device that could significantly affect the safety or effectiveness of the device without submitting a 510(k) to FDA. Specifically, changing the volume of the syringe, switching from a luer lock to a luer slip syringe tip, and changing from a traditional syringe to a control syringe could result in the risk of patient harm such as inaccurate dosing, a leaking device, a higher risk of inappropriate needle detachment, and incorrect device handling. Furthermore, the addition of color additives to your syringe could result in adverse health effects such as allergic reactions, skin irritation or inflammation, pain, fever, red blood cell damage that induces organ stress, and toxicity that leads to loss of organ function or failure. Labeling the syringe for a specific drug can also cause harm because differences in drug viscosities impact the function of the syringe and can result in patient harm such as inaccurate dosing or incorrect drug usage.\n\nYour firm's failure to submit 510(k)s for these devices has prevented FDA from evaluating the risks posed by these substantially different technological characteristics or from determining that there is reasonable assurance of the safety and effectiveness of these modified devices such that they may be legally marketed syringes. Further, FDA has observed evidence of postmarket safety signals indicating product quality issues that have the potential to cause serious patient harm. Specifically, FDA is aware of multiple customer complaints regarding quality issues (e.g. cracks, breakage during use) for syringes in surgical kits supplied by Jiangsu Shenli Medical Production Co. Ltd.\n\nFor a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http:\u002F\u002Fwww.fda.gov\u002FMedicalDevices\u002FDeviceRegulationandGuidance\u002FHowtoMarketYourDevice\u002Fdefault.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.\n\nFDA requests that Jiangsu Shenli Medical Production Factory cease any activities that result in the misbranding or adulteration of all the Jiangsu Shenli Medical Production Co. Ltd. piston syringe configurations listed in Table 1, such as the commercial distribution of the device sizes, configurations, and uses discussed above, including selling to initial importers, distributors, or other third parties for distribution and use within the United States or otherwise representing these devices to have the requisite clearance or authorization for marketing in the United States.\n\nGiven the serious nature of the violations of the Act and growing evidence of potential harm, all the Jiangsu Shenli Medical Production Co. Ltd. piston syringes configurations listed in Table 1 are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated. As a result, FDA is taking steps to refuse entry of these devices into the United States, until these violations are addressed.\n\nPlease notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and\u002For corrective actions (which must address systemic problems) your firm has taken. If your firm's planned corrections and\u002For corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and\u002For corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm's response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration as part of your response.\n\nYour firm's response should be sent by email to CDRHWamingLetterResponses@fda.hhs.gov or by mail to:\n\nFood and Drug Administration\n\nCenter for Devices and Radiological Health\n\nOffice of Regulatory Programs\n\nDivision of Regulatory Programs 2: Establishment Support\n\nRegulatory Inspections and Audits Team\n\nWhite Oak Building 66\n\n10903 New Hampshire Ave.\n\nSilver Spring, MD 20993\n\nRefer to the identification number CMS # 677753 when replying. We remind you that only written communication is considered as official. If you have any questions about the contents of this letter, please contact: Shruti Misty at Shruti.Mistry@fda.hhs.gov.\n\nFinally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm. It is your firm's responsibility to ensure compliance with the applicable laws and regulations administered by FDA.\n\nSincerely yours,\n\n\u002FS\u002F\n\nKellie B. Kelm, Ph.D.\n\nActing Director\n\nOHT3: Office of GastroRenal, ObGyn,\n\nGeneral Hospital and Urology Devices\n\nOffice of Product Evaluation and Quality\n\nCenter for Devices and Radiological Health\n\nCc:\n\nOfficial correspondent:\n\nCai Xiaotian at (b)(4)\n\nUS Agent:\n\nCharles Mack\n\nIRC USA\n\n2950 E Lindrick Dr\n\nChandler, AZ, US 85249\n\nEmail: (b)(4) or (b)(4)","2026-08-20T00:13:56.316+00:00",[22,23,24,9,10,25,25,25],"\u003Ctime datetime=\"2024-03-19T18:00:00Z\">03\u002F19\u002F2024\u003C\u002Ftime>\n","\u003Ctime datetime=\"2024-03-18T04:00:00Z\">03\u002F18\u002F2024\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fjiangsu-shenli-medical-production-co-ltd-677753-03182024\">Jiangsu Shenli Medical Production Co., Ltd.\u003C\u002Fa>","","2026-08-18T06:42:28.994808+00:00","2026-08-20T02:24:56.185295+00:00",{"510k":29,"classification":30,"enforcement":31,"event":32,"pma":33,"warning_letter":34},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-20T03:28:02.95+00:00"]