Fei Fah Medical Manufacturing Pte. Ltd. – FDA Warning Letter, Jan 31, 2023

This FDA Warning Letter, dated January 30, 2023, addresses Fei Fah Medical Manufacturing Pte. Ltd., an OTC drug product manufacturer in Singapore. The letter summarizes significant Current Good Manufacturing Practice (CGMP) violations identified during a review of records submitted in response to a May 18, 2021, request. The FDA determined the firm's drug products are adulterated under 21 U.S.C. 351(a)(2)(B) due to non-conforming manufacturing methods, facilities, or controls.

Key violations include: 1. **Failure to establish an adequate stability testing program (21 CFR 211.166(a)):** The firm lacks sufficient stability data to support the assigned expiration date for its drug product and has not established specifications or tested for impurities/degradants using stability-indicating methods. The provided two years of data for one batch were deemed insufficient, and the firm did not commit to comprehensive testing or evaluation of distributed batches. 2. **Failure to establish adequate laboratory controls (21 CFR 211.160(b)):** The firm did not demonstrate the suitability of test methods for its drug product and APIs, nor establish appropriate release specifications for impurities. Specifically, the assay method for APIs in the finished product was not validated, and the firm failed to commit to impurity testing at release. 3. **Failure