Wipro Unza Singapore Private, Limited Warning Letter Details

Summary

Wipro Unza Singapore Private, Limited, a manufacturer of over-the-counter drug products including hand sanitizers, failed to provide access to and copying of records requested by FDA pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act. The company did not respond to three separate FDA requests for records issued between June and October 2022, and initially denied exporting products to the United States despite import records showing multiple shipments of OTC drug products. The firm's non-compliance persisted despite follow-up communications including a telephone conversation with the company's registered U.S. Agent and a teleconference in May 2023 where the company committed to providing additional information.