FDA WARNING_LETTER - Zenzi Pharmaceutical Industries Pvt. Ltd. - February 13, 2025

This FDA Warning Letter, dated February 13, 2025, addresses Zenzi Pharmaceutical Industries Pvt. Ltd., a contract manufacturer of prescription drug products for the U.S. market. The letter stems from the firm's failure to respond to multiple electronic and written requests for records and information, initiated on October 29, 2024, under section 704(a)(4) of the FD&C Act.

Despite confirmed delivery and evidence from a customer's contract manufacturing agreement, registration file, certificate of analysis, and batch production records confirming Zenzi as the manufacturer of (b)(4) (b)(4) Injection USP shipped to the U.S., the firm's Vice President of Quality denied supplying the product. This refusal to provide access to or copying of records is a prohibited act under section 301(e) of the FD&C Act.

Due to the lack of response, the FDA has no indication of the quality assurance level for drugs manufactured by Zenzi. Consequently, all drugs and drug products from Zenzi Pharmaceutical Industries Pvt. Ltd. were placed on Import Alert 66-79 on February 12, 2025. The FDA may withhold approval of new applications or supplements listing Zenzi as a drug manufacturer until compliance with Current Good Manufacturing Practice (CGMP) is confirmed. Shipments to the U.S. are subject to detention or refusal under section