Yahon Enterprise Co., Ltd. – FDA Warning Letter, Dec 21, 2023

On June 5, 2024, the FDA issued a Warning Letter to Yahon Enterprise Co. Ltd. following an inspection from December 15 to 21, 2023. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Failure to test drug products prior to release (21 CFR 211.165(a)):** The firm released OTC drug products, including ethyl alcohol antiseptic wipes, without adequate identity and strength testing of active ingredients. The company's response was inadequate, lacking justification for testing methods and comparability to USP standards. 2. **Failure to test components for conformity (21 CFR 211.84(d)(2)):** The firm did not perform adequate identity testing on each lot of ethyl alcohol and benzylkonium chloride. Their commitment to third-party testing was deemed inadequate due to lack of specificity. The letter also highlighted the risk of methanol contamination in ethanol-containing products. 3. **Unsupported expiration dates (21 CFR 211.137(a)):** A three-year expiry period for ethyl alcohol antiseptic wipes lacked scientific rationale and supporting stability data. The firm's response, citing accelerated stability and "quality confirmation," was