Zenzi Pharmaceutical Industries Pvt. Ltd.

Warning LetterOpen

Mr. Jacob Sporon-Fiedler Managing Director Zenzi Pharmaceutical Industries Pvt. Ltd. Plot No. H-53, Additional Murbad M.I.D.C. Kudavali Dist. Thane 421401 Maharashtra IndiaFEI 3032916295Issued Feb 13, 2025Center for Drug Evaluation and Research (CDER)

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3032916295.

Violations1

Issue DateFeb 13, 2025

Product TypeOther

StatusOpen

Letter Details

Firm: Zenzi Pharmaceutical Industries Pvt. Ltd.
Location: Mr. Jacob Sporon-Fiedler Managing Director Zenzi Pharmaceutical Industries Pvt. Ltd. Plot No. H-53, Additional Murbad M.I.D.C. Kudavali Dist. Thane 421401 Maharashtra India
FEI Number: 3032916295
Country: India
Issue Date: February 13, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Other
Status: Open

Summary

Zenzi Pharmaceutical Industries Pvt. Ltd., a contract manufacturer of prescription drug products, violated federal law by refusing to provide access to manufacturing records requested by the FDA. The company received three separate record requests between October 29 and November 15, 2024—via email and certified mail—but failed to respond or provide the requested documentation, including certificates of analysis and batch production records for injectable products shipped to the United States. The firm's Vice President of Quality contradicted customer records by falsely claiming the company did not manufacture the product in question, in direct violation of section 704(a) of the Federal Food, Drug, and Cosmetic Act. This refusal to comply with mandatory record access requirements constituted a prohibited act under section 301(e) of the FD&C Act.

Zenzi Pharmaceutical Industries Pvt. Ltd. FDA Warning Letter, February 13, 2025