Zenzi Pharmaceutical Industries Private Limited

CLOSEOUT LETTER Zenzi Pharmaceutical Industries Private Limited MARCS-CMS 701130 — September 18, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: FEI 3032916295 Product: Drugs Recipient: Recipient Name Jacob Sporon-Fiedler Recipient Title CEO/Managing Director Zenzi Pharmaceutical Industries Private Limited Plot No. H-53, Additional Murbad M.I.D.C. Kudavali, Dist. Thane 421401 Maharashtra India Issuing Office: Center for Drug Evaluation and Research (CDER) United States Secondary Issuing Offices United States 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 Content current as of: 09/24/2026 Regulated Product(s) Drugs