Zenzi Pharma Gets Import Alert 66-79 After Ignoring FDA Requests

Non-response to an FDA records request is itself a compliance event, and Zenzi Pharmaceutical Industries Pvt. Ltd. is now on Import Alert 66-79 to prove it. The Maharashtra-based contract manufacturer failed to answer three successive section 704(a)(4) requests between October and November 2024, prompting FDA's Center for Drug Evaluation and Research (CDER) to place all drugs manufactured at the facility on import alert on February 12, 2025, one day before the warning letter was issued.

The sequence is instructive for any contract manufacturer supplying the U.S. market. FDA's first electronic request, sent October 29, 2024 to the contact address listed in a customer's contract manufacturing agreement, went unanswered. A follow-up written request confirmed delivered by the shipper on November 7 drew a response from Zenzi's Vice President of Quality on November 13, but that response denied manufacturing the product in question, a position directly contradicted by records the product owner had already provided to the Agency. Those records included Zenzi's own registration file, certificate of analysis, and a batch production record. A third request on November 15 received no reply.

Under section 301(e) of the FD&C Act (21 U.S.C. 331(e)), refusing to permit access to records required by section 704(a) constitutes a prohibited act. FDA's warning letter, signed by Francis Godwin, Director of the Office of Manufacturing Quality, states explicitly that the Agency has "no indication of the level of quality assurance for drugs listed as manufactured at your facility", language that signals the import alert was triggered not by a documented CGMP deficiency found during inspection, but by the absence of any verifiable quality data at all.

The regulatory consequences compound quickly. New drug applications or supplements listing Zenzi (FEI 3032916295) as a manufacturer are subject to approval withholding until CGMP compliance is confirmed. Shipments already in transit that appear adulterated or misbranded face detention or refusal under section 801(a)(3) of the FD&C Act. The facility has 15 working days from receipt of the letter to respond in writing to CDER, with the option to request a scheduled FDA inspection as part of that response.

For QA directors and regulatory affairs leads at contract manufacturing organizations, the case reinforces a straightforward operational checkpoint: 704(a)(4) requests carry the same legal weight as an inspection notice, and a denial of manufacturing activity that contradicts customer-supplied documentation will accelerate, not delay, enforcement action.

Zenzi's path back to U.S. market access runs through a confirmed CGMP compliance determination, a timeline that will depend heavily on the adequacy of its written response and whether FDA elects to schedule a physical inspection of the Thane facility.

Source: FDA CDER via Warning Letters database, February 13, 2025.