[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-zenzi-pharmaceutical-industries-pvt-ltd-701130-02132025":3,"fda-latest-sync-dates":30},{"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":15,"marcs_cms_no":16,"product_type":17,"delivery_method":18,"recipient_name":19,"recipient_title":8,"body_html":20,"body_text":21,"body_fetched_at":22,"medical_device_id":8,"raw":23,"created_at":28,"updated_at":29},1058,"zenzi-pharmaceutical-industries-pvt-ltd-701130-02132025","Warning Letter","Zenzi Pharmaceutical Industries Pvt. Ltd.",null,"Center for Drug Evaluation and Research (CDER)","Refusal to Provide Access to and Copying of Records","2025-02-18","2025-02-13","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fzenzi-pharmaceutical-industries-pvt-ltd-701130-02132025","320-25-45","701130","Drugs","VIA UPS","Mr. Jacob Sporon-Fiedler","\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              \u003Cdt class=\"cell-1_2\">Reference #:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_2\">320-25-45\u003C\u002Fdd>\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\">Mr. Jacob Sporon-Fiedler\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>Zenzi Pharmaceutical Industries Pvt. Ltd.\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">Plot No. H-53, Additional Murbad M.I.D.C.\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"address-line2\">Kudavali\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Dist. Thane\u003C\u002Fspan> \u003Cspan class=\"postal-code\">421401\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"administrative-area\">Maharashtra\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"country\">India\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> 320-25-45\u003C\u002Fp>\u003Cp>February 13, 2025\u003C\u002Fp>\u003Cp>Dear Mr. Sporon-Fiedler:\u003C\u002Fp>\u003Cp>Your facility is registered with the United States Food and Drug Administration (FDA or Agency) as a manufacturer of prescription drug products. A review of records showed that you are a contract manufacturing facility of prescription drug product that was delivered into the United States. On October 29, 2024, the FDA sent an electronic request for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 374(a)(4), to the contact e-mail provided in your customer’s contract manufacturing agreement. This request went unanswered. The Agency sent a follow-up written request for such records and other information on November 7, 2024. Delivery to you was confirmed by the shipper. On November 13, 2024, your Vice President of Quality responded via e-mail stating your firm does not supply \u003Cstrong>(b)(4)\u003C\u002Fstrong> (\u003Cstrong>(b)(4)\u003C\u002Fstrong> Injection USP) labeled with the address of \u003Cstrong>(b)(4)\u003C\u002Fstrong> (your customer). This is in contradiction to records provided by your customer. A third request was sent via e-mail on November 15, 2024. You failed to respond to these attempted communications or otherwise provide the requested records or other information. Pursuant to section 704(a)(4), FDA’s request and follow-up communications included a sufficient and clear description of the records sought.\u003C\u002Fp>\u003Cp>A contract manufacturing agreement provided by the \u003Cstrong>(b)(4)\u003C\u002Fstrong> owner and other records show that you are the manufacturer of \u003Cstrong>(b)(4)\u003C\u002Fstrong>, which was shipped to the United States. These records include your registration file, your certificate of analysis, and a batch production record for \u003Cstrong>(b)(4)\u003C\u002Fstrong>.\u003C\u002Fp>\u003Cp>It is a prohibited act under section 301(e) of the FD&C Act (21 U.S.C. 331(e)) to refuse to permit access to or copying of any record as required by section 704(a). Because your firm failed to respond to the section 704(a)(4) records requests and associated communication attempts, we have no indication of the level of quality assurance for drugs listed as manufactured at your facility.\u003C\u002Fp>\u003Cp>FDA placed all drugs and drug products manufactured by your firm on Import Alert 66-79 on February 12, 2025.\u003C\u002Fp>\u003Cp>Until FDA is able to confirm compliance with Current Good Manufacturing Practice (CGMP) and other applicable requirements, we may withhold approval of any new applications or supplements listing your firm as a drug manufacturer. In addition, shipments of articles manufactured at Zenzi Pharmaceutical Industries Pvt. Ltd., FEI 3032916295, located at Plot No. H-53, Additional Murbad M.I.D.C., Kudavali, Dist. Thane, Maharashtra, India, 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>After you receive this letter, respond to this office in writing within 15 working days. In response to this letter, you may provide 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 3032916295 and ATTN: Kevin Maguire.\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:\u003Cbr>Registered U.S. Agent:\u003Cbr>\u003Cstrong>(b)(4)\u003C\u002Fstrong>\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 UPS\n\nReference #:\n\n320-25-45\n\nProduct:\n\nDrugs\n\nRecipient:\n\nRecipient Name\n\nMr. Jacob Sporon-Fiedler\n\nRecipient Title\n\nManaging Director\n\nZenzi Pharmaceutical Industries Pvt. Ltd.\n\nPlot No. H-53, Additional Murbad M.I.D.C.\n\nKudavali\n\nDist. Thane 421401\n\nMaharashtra\n\nIndia\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research (CDER)\n\nUnited States\n\nWarning Letter 320-25-45\nFebruary 13, 2025\nDear Mr. Sporon-Fiedler:\nYour facility is registered with the United States Food and Drug Administration (FDA or Agency) as a manufacturer of prescription drug products. A review of records showed that you are a contract manufacturing facility of prescription drug product that was delivered into the United States. On October 29, 2024, the FDA sent an electronic request for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 374(a)(4), to the contact e-mail provided in your customer’s contract manufacturing agreement. This request went unanswered. The Agency sent a follow-up written request for such records and other information on November 7, 2024. Delivery to you was confirmed by the shipper. On November 13, 2024, your Vice President of Quality responded via e-mail stating your firm does not supply (b)(4) ((b)(4) Injection USP) labeled with the address of (b)(4) (your customer). This is in contradiction to records provided by your customer. A third request was sent via e-mail on November 15, 2024. You failed to respond to these attempted communications or otherwise provide the requested records or other information. Pursuant to section 704(a)(4), FDA’s request and follow-up communications included a sufficient and clear description of the records sought.\nA contract manufacturing agreement provided by the (b)(4) owner and other records show that you are the manufacturer of (b)(4), which was shipped to the United States. These records include your registration file, your certificate of analysis, and a batch production record for (b)(4).\nIt is a prohibited act under section 301(e) of the FD&C Act (21 U.S.C. 331(e)) to refuse to permit access to or copying of any record as required by section 704(a). Because your firm failed to respond to the section 704(a)(4) records requests and associated communication attempts, we have no indication of the level of quality assurance for drugs listed as manufactured at your facility.\nFDA placed all drugs and drug products manufactured by your firm on Import Alert 66-79 on February 12, 2025.\nUntil FDA is able to confirm compliance with Current Good Manufacturing Practice (CGMP) and other applicable requirements, we may withhold approval of any new applications or supplements listing your firm as a drug manufacturer. In addition, shipments of articles manufactured at Zenzi Pharmaceutical Industries Pvt. Ltd., FEI 3032916295, located at Plot No. H-53, Additional Murbad M.I.D.C., Kudavali, Dist. Thane, Maharashtra, India, 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).\nAfter you receive this letter, respond to this office in writing within 15 working days. In response to this letter, you may provide 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 3032916295 and ATTN: Kevin Maguire.\nSincerely,\n\u002FS\u002F\nFrancis Godwin\nDirector\nOffice of Manufacturing Quality\nOffice of Compliance\nCenter for Drug Evaluation and Research\nCC:\nRegistered U.S. Agent:\n(b)(4)","2026-08-19T17:02:15.504+00:00",[24,25,26,9,10,27,27,27],"\u003Ctime datetime=\"2025-02-18T05:00:00Z\">02\u002F18\u002F2025\u003C\u002Ftime>\n","\u003Ctime datetime=\"2025-02-13T05:00:00Z\">02\u002F13\u002F2025\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fzenzi-pharmaceutical-industries-pvt-ltd-701130-02132025\">Zenzi Pharmaceutical Industries Pvt. Ltd.\u003C\u002Fa>","","2026-08-18T06:42:28.856152+00:00","2026-08-20T02:24:56.037289+00:00",{"510k":31,"classification":32,"enforcement":33,"event":34,"pma":35,"warning_letter":36},"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"]