Wipro Unza Singapore Private, Limited – FDA Warning Letter, Dec 26, 2023

This FDA Warning Letter, dated December 21, 2023, addresses WIPRO Consumer Care Vietnam Company, Limited, a registered manufacturer of OTC drug products, including Aiken Hand Sanitizer. The firm failed to respond to multiple FDA requests for records and information under section 704(a)(4) of the FD&C Act, starting June 16, 2022, despite confirmed delivery and follow-up communications.

Import records indicated the firm shipped OTC drug products to the U.S., contradicting a statement from their Head of Legal on October 10, 2022, denying U.S. exports or distribution plans. Although the firm's FDA registration expired December 31, 2022, and a consultant stated no future U.S. shipments, the failure to provide requested 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 the firm. Consequently, the FDA publicly notified consumers on July 5, 2023, about the firm's non-response and placed all drugs manufactured by the firm on Import Alert 66-79 on August 11, 2023. The FDA may withhold approval of new applications or supplements listing the firm as a drug manufacturer until CGMP compliance is confirmed.