[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-mei-lan-thailand-co-ltd-672783-01222024":3,"fda-latest-sync-dates":29},{"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":17,"recipient_name":18,"recipient_title":8,"body_html":19,"body_text":20,"body_fetched_at":21,"medical_device_id":8,"raw":22,"created_at":27,"updated_at":28},1641,"mei-lan-thailand-co-ltd-672783-01222024","Warning Letter","Mei Lan Thailand Co., Ltd.",null,"Center for Drug Evaluation and Research | CDER","CGMP\u002FActive Pharmaceutical Ingredient (API)\u002FAdulterated\u002FRefused Inspection","2024-01-30","2024-01-22","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fmei-lan-thailand-co-ltd-672783-01222024","672783","Drugs","VIA UPS","Mrs. Lan Pu","\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 UPS\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\">Mrs. Lan Pu\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\">Managing Director\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Mei Lan Thailand Co., Ltd.\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">35\u002F252-253 Moo 2, Tambol Bangnamched, Muang District\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"dependent-locality\">Muang Samut Sakhon\u003C\u002Fspan>,\u003Cbr>\n\u003Cspan class=\"administrative-area\">Samut Sakhon\u003C\u002Fspan> \u003Cspan class=\"postal-code\">74000\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"country\">Thailand\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  \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> 320-24-16\u003C\u002Fp>\n\n\u003Cp>January 22, 2024\u003Cbr>\n\u003Cbr>\nDear Mrs. Lan Pu:\u003C\u002Fp>\n\n\u003Cp>The U.S. Food and Drug Administration (FDA) notified your site, Mei Lan (Thailand) Co., Ltd., FEI 3012190301, at 35\u002F252-253 Moo 2 , Tambol Bangnamched, Muang District, Muang Samut Sakhon, Samutsakorn, Thailand, of a planned inspection of your drug manufacturing facility from September 18 to 22, 2023.\u003C\u002Fp>\n\n\u003Cp>Your firm is registered as an active pharmaceutical ingredient (API) manufacturer and manufactures crude \u003Cstrong>(b)(4)\u003C\u002Fstrong>.\u003C\u002Fp>\n\n\u003Cp>On May 23, 2023, the FDA sent an electronic notice of inspection to the contact email address provided in your registration file. This request went unanswered, as did the second and third email requests sent on June 6 and 21, 2023, respectively. An FDA representative then attempted to contact your U.S. Agent on August 25, 2023. A fourth email attempt to contact you was sent on August 29, 2023, but you failed to respond. The Agency then sent a follow-up written request via UPS, that was delivered to the physical address provided in your registration file on August 29, 2023. Delivery to you was confirmed by the shipper, but you failed to respond.\u003C\u002Fp>\n\n\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 that delays, denies, or limits an inspection, or refuses to permit entry or inspection.\u003C\u002Fp>\n\n\u003Cp>See FDA’s guidance document, \u003Cem>Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection\u003C\u002Fem>, at https:\u002F\u002Fwww.fda.gov\u002Fdownloads\u002Fregulatoryinformation\u002Fguidances\u002Fucm360484.pdf.\u003C\u002Fp>\n\n\u003Cp>FDA placed your firm on Import Alert 55-03 on January 18, 2024.\u003C\u002Fp>\n\n\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 Mei Lan (Thailand) Co., Ltd., at 35\u002F252-253 Moo 2, Tambol Bangnamched, Muang District, Muang Samut Sakhon, Samutsakorn, Thailand 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>\n\n\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>\n\n\u003Cp>Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3012190301 and ATTN: Rokhsana Jazi.\u003C\u002Fp>\n\n\u003Cp>Sincerely,\u003Cbr>\n\u002FS\u002F\u003C\u002Fp>\n\n\u003Cp>Francis Godwin\u003Cbr>\nDirector\u003Cbr>\nOffice of Manufacturing Quality\u003Cbr>\nOffice of Compliance\u003Cbr>\nCenter for Drug Evaluation and Research\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            ","Delivery Method:\n\nVIA UPS\n\nProduct:\n\nDrugs\n\nRecipient:\n\nRecipient Name\n\nMrs. Lan Pu\n\nRecipient Title\n\nManaging Director\n\nMei Lan Thailand Co., Ltd.\n\n35\u002F252-253 Moo 2, Tambol Bangnamched, Muang District\n\nMuang Samut Sakhon,\n\nSamut Sakhon 74000\n\nThailand\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research | CDER\n\nUnited States\n\nSecondary Issuing Offices\n\nUnited States\n\nWarning Letter 320-24-16\n\nJanuary 22, 2024\n\nDear Mrs. Lan Pu:\n\nThe U.S. Food and Drug Administration (FDA) notified your site, Mei Lan (Thailand) Co., Ltd., FEI 3012190301, at 35\u002F252-253 Moo 2 , Tambol Bangnamched, Muang District, Muang Samut Sakhon, Samutsakorn, Thailand, of a planned inspection of your drug manufacturing facility from September 18 to 22, 2023.\n\nYour firm is registered as an active pharmaceutical ingredient (API) manufacturer and manufactures crude (b)(4).\n\nOn May 23, 2023, the FDA sent an electronic notice of inspection to the contact email address provided in your registration file. This request went unanswered, as did the second and third email requests sent on June 6 and 21, 2023, respectively. An FDA representative then attempted to contact your U.S. Agent on August 25, 2023. A fourth email attempt to contact you was sent on August 29, 2023, but you failed to respond. The Agency then sent a follow-up written request via UPS, that was delivered to the physical address provided in your registration file on August 29, 2023. Delivery to you was confirmed by the shipper, but you failed to respond.\n\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 that delays, denies, or limits an inspection, or refuses to permit entry or inspection.\n\nSee FDA’s guidance document, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection, at https:\u002F\u002Fwww.fda.gov\u002Fdownloads\u002Fregulatoryinformation\u002Fguidances\u002Fucm360484.pdf.\n\nFDA placed your firm on Import Alert 55-03 on January 18, 2024.\n\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 Mei Lan (Thailand) Co., Ltd., at 35\u002F252-253 Moo 2, Tambol Bangnamched, Muang District, Muang Samut Sakhon, Samutsakorn, Thailand 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).\n\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.\n\nSend your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3012190301 and ATTN: Rokhsana Jazi.\n\nSincerely,\n\n\u002FS\u002F\n\nFrancis Godwin\n\nDirector\n\nOffice of Manufacturing Quality\n\nOffice of Compliance\n\nCenter for Drug Evaluation and Research","2026-08-20T00:21:27.949+00:00",[23,24,25,9,10,26,26,26],"\u003Ctime datetime=\"2024-01-30T14:20:00Z\">01\u002F30\u002F2024\u003C\u002Ftime>\n","\u003Ctime datetime=\"2024-01-22T05:00:00Z\">01\u002F22\u002F2024\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fmei-lan-thailand-co-ltd-672783-01222024\">Mei Lan Thailand Co., Ltd.\u003C\u002Fa>","","2026-08-18T06:42:28.994808+00:00","2026-08-20T02:24:56.185295+00:00",{"510k":30,"classification":31,"enforcement":32,"event":33,"pma":34,"warning_letter":35},"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"]