Zenzi Pharmaceutical Industries Pvt. Ltd.

Warning Letter 320-25-45

February 13, 2025

Dear Mr. Sporon-Fiedler:

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 (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.

A 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).

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.

FDA placed all drugs and drug products manufactured by your firm on Import Alert 66-79 on February 12, 2025.

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).

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/or submit a request to schedule an FDA inspection.

Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3032916295 and ATTN: Kevin Maguire.

Sincerely,
/S/

Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research

CC:
Registered U.S. Agent:
(b)(4)

Dear Mr. Sporon-Fiedler:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s responses to our Warning Letter 320-25-45 dated February 13, 2025, and our subsequent 704(a)(4) request for records issued on May 22, 2026.

Based on our evaluation, it appears that you have addressed the matter contained in this Warning Letter, and our records request.

While the available information provided in your responses indicate that you do not manufacture human drugs for the U.S. market, FDA has not had the opportunity to verify, via onsite inspection, CGMP compliance. Since you have indicated you are not willing to be inspected, your firm will remain on Import Alert 66-79.

Although we consider this matter closed, note that if you decide to manufacture human drugs in the future for the U.S. market, any human drugs you manufacture will be subject to the requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and failure to manufacture human drugs in accordance with CGMP requirements would cause those drugs to be adulterated.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the FD&C Act and its implementing regulations or with other relevant legal authority.

The FDA expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during an inspection or through other means.

Sincerely,
/S/
Milind Ganjawala
Director
Division of Drug Quality III
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research