FDA WARNING_LETTER - Xiamen Wally Bath Manufacture Co., Ltd. - November 08, 2023

This FDA Warning Letter (320-24-06), dated November 15, 2023, was issued to Xiamen Wally Bath Manufacture Co., Ltd. (FEI 3009675687), a manufacturer of OTC drug products. The letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR, parts 210 and 211), rendering their drug products adulterated under section 501(a)(2)(B) of the FD&C Act.

The violations were identified during a review of records submitted in response to Section 704(a)(4) requests from June and July 2022. Key deficiencies include:

1. **Failure to verify component identity (21 CFR 211.84(d)(1)):** The firm relied solely on supplier Certificates of Analysis (COAs) for raw material identity, including ethanol, and did not test for methanol in incoming ethanol lots or provide methanol specifications. 2. **Failure to conduct adequate finished product testing (21 CFR 211.165(a)):** The firm did not demonstrate full chemical and microbiological testing of OTC finished drug products, including identity and strength of active ingredients, prior to release for U.S. distribution. 3. **Failure to establish an adequate stability testing program (21 CFR