[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-kellin-chemicals-co-ltd-716228-zhangjiagang":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":8,"product_type":15,"delivery_method":16,"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},21718,"kellin-chemicals-co-ltd-716228-zhangjiagang","Warning Letter","Kellin Chemicals Co., Ltd. - Zhangjiagang",null,"Center for Drug Evaluation and Research (CDER)","CGMP\u002FActive Pharmaceutical Ingredient (API)\u002FAdulterated","2026-09-29","2025-11-06","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fkellin-chemicals-co-ltd-716228-zhangjiagang","Drugs","Via Email Return Receipt Requested","Zhiyu Du","\n\n                            \n                            \n                            \n                            \n                                              \n  \n \n\n                 \n\n  \u003Chr>\n \n\n\u003Cdiv class=\"inset-column\">\n  \u003Cdl class=\"lcds-description-list--grid\">\n\n              \u003Cdt class=\"cell-1_1\">Delivery Method:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_1\">Via Email Return Receipt Requested\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\n      \n      \n              \u003Cdt class=\"cell-1_3\">Product:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_3\">Drugs                          \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\">Zhiyu Du\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\">Marketing and Sales Center Representative \u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Kellin Chemicals Co., Ltd. - Zhangjiagang\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">No. 5 Changjiang North Road\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"address-line2\">Yangzijiang Chemical Industrial Park\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Zhenjiang Shi\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"administrative-area\">Jiangsu Sheng\u003C\u002Fspan>, \u003Cspan class=\"postal-code\">215634\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"country\">China\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \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 Drug Evaluation and Research (CDER)\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    \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> 320-26-15\u003C\u002Fp>\u003Cp>November 6, 2025\u003C\u002Fp>\u003Cp>Dear Zhiyu Du:\u003C\u002Fp>\u003Cp>Your firm is currently registered as a supplier of active pharmaceutical ingredients (API) (for example, \u003Cstrong>(b)(4)\u003C\u002Fstrong>) to manufacturers of finished drug products who have distributed to the U.S. market.\u003C\u002Fp>\u003Cp>The United States Food and Drug Administration (FDA) notified your site, Kellin Chemicals (Zhangjiagang) Co., Ltd., FEI 3017343300, at No. 5 Changjiang North Road, Yangzijiang Chemical Industrial Park, Zhangjiagana, Jiangsu, of a planned inspection of your drug manufacturing facility from July 7 to July 11, 2025. Your United States (U.S.) Agent, Registrar Corp., notified us that your firm refused the preannounced inspection.\u003C\u002Fp>\u003Cp>Under section 501(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(j), your drugs are adulterated in that they have been manufactured, processed, packed, or held in an establishment where the owner or operator has delayed, denied, limited, and\u002For refused to permit inspection.\u003C\u002Fp>\u003Cp>Until FDA is permitted to inspect your facility and confirms compliance with CGMP, we may withhold approval of any new applications or supplements listing your firm as a drug manufacturer. In addition, shipments of articles manufactured at Kellin Chemicals (Zhangjiagang) Co., Ltd., No. 5 Changjiang North Road, Yangzijiang Chemical Industrial Park, Zhangjiagana, Jiangsu, into the United States. that appear to be adulterated or misbranded are subject to being detained or refused admission pursuant to section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3).\u003C\u002Fp>\u003Cp>We recommend that you inform any U.S. customers of this letter. Introduction into interstate commerce of adulterated drugs violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a); and receipt in interstate commerce of adulterated drugs, and the delivery or proffered delivery thereof, such as by drug product manufacturers using adulterated API as a component, is a violation of section 301(c) of the FD&C Act, 21 U.S.C. 331(c).\u003C\u002Fp>\u003Cp>After you receive this letter, respond to this office in writing within 15 working days. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices, and\u002For submit a request to schedule an FDA inspection.\u003C\u002Fp>\u003Cp>Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3017343300 and ATTN: Maria Pavco.\u003C\u002Fp>\u003Cp>Sincerely,\u003Cbr>\u002FS\u002F\u003C\u002Fp>\u003Cp>Francis Godwin\u003Cbr>Director\u003Cbr>Office of Manufacturing Quality\u003Cbr>Office of Compliance\u003Cbr>Center for Drug Evaluation and Research\u003C\u002Fp>\u003Cp>Cc: Registrar Corp\u003C\u002Fp>\n\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\n\n\n              \n                                            \n              \n            ","Delivery Method:\n\nVia Email Return Receipt Requested\n\nProduct:\n\nDrugs\n\nRecipient:\n\nRecipient Name\n\nZhiyu Du\n\nRecipient Title\n\nMarketing and Sales Center Representative\n\nKellin Chemicals Co., Ltd. - Zhangjiagang\n\nNo. 5 Changjiang North Road\n\nYangzijiang Chemical Industrial Park\n\nZhenjiang Shi\n\nJiangsu Sheng, 215634\n\nChina\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research (CDER)\n\nUnited States\n\nWarning Letter 320-26-15\nNovember 6, 2025\nDear Zhiyu Du:\nYour firm is currently registered as a supplier of active pharmaceutical ingredients (API) (for example, (b)(4)) to manufacturers of finished drug products who have distributed to the U.S. market.\nThe United States Food and Drug Administration (FDA) notified your site, Kellin Chemicals (Zhangjiagang) Co., Ltd., FEI 3017343300, at No. 5 Changjiang North Road, Yangzijiang Chemical Industrial Park, Zhangjiagana, Jiangsu, of a planned inspection of your drug manufacturing facility from July 7 to July 11, 2025. Your United States (U.S.) Agent, Registrar Corp., notified us that your firm refused the preannounced inspection.\nUnder section 501(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(j), your drugs are adulterated in that they have been manufactured, processed, packed, or held in an establishment where the owner or operator has delayed, denied, limited, and\u002For refused to permit inspection.\nUntil FDA is permitted to inspect your facility and confirms compliance with CGMP, we may withhold approval of any new applications or supplements listing your firm as a drug manufacturer. In addition, shipments of articles manufactured at Kellin Chemicals (Zhangjiagang) Co., Ltd., No. 5 Changjiang North Road, Yangzijiang Chemical Industrial Park, Zhangjiagana, Jiangsu, into the United States. that appear to be adulterated or misbranded are subject to being detained or refused admission pursuant to section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3).\nWe recommend that you inform any U.S. customers of this letter. Introduction into interstate commerce of adulterated drugs violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a); and receipt in interstate commerce of adulterated drugs, and the delivery or proffered delivery thereof, such as by drug product manufacturers using adulterated API as a component, is a violation of section 301(c) of the FD&C Act, 21 U.S.C. 331(c).\nAfter you receive this letter, respond to this office in writing within 15 working days. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices, and\u002For submit a request to schedule an FDA inspection.\nSend your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3017343300 and ATTN: Maria Pavco.\nSincerely,\n\u002FS\u002F\nFrancis Godwin\nDirector\nOffice of Manufacturing Quality\nOffice of Compliance\nCenter for Drug Evaluation and Research\nCc: Registrar Corp","2026-10-14T12:35:07.613+00:00",[22,23,24,9,10,25,25,25],"\u003Ctime datetime=\"2026-09-29T04:00:00Z\">09\u002F29\u002F2026\u003C\u002Ftime>\n","\u003Ctime datetime=\"2025-11-06T05:00:00Z\">11\u002F06\u002F2025\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fkellin-chemicals-co-ltd-716228-zhangjiagang\">Kellin Chemicals Co., Ltd. - Zhangjiagang\u003C\u002Fa>","","2026-10-14T12:31:16.41489+00:00","2026-10-14T14:44:01.489557+00:00",{"510k":29,"classification":30,"enforcement":31,"event":32,"event_backfill":33,"pma":34,"warning_letter":35},"2026-10-12T02:00:50.914+00:00","2026-10-12T02:00:38.521+00:00","2026-10-12T02:00:45.002+00:00","2026-10-14T04:02:53.8+00:00","2026-09-07T05:17:28.839+00:00","2026-10-12T02:00:52.377+00:00","2026-10-14T14:44:02.318+00:00"]