YangZhou SuXiang Medical Instrument Co., Ltd. – FDA Warning Letter, Jul 16, 2024

The FDA issued a Warning Letter to YangZhou SuXiang Medical Instrument Co., Ltd. on July 8, 2024, following a review of records submitted in response to an August 15, 2022 request. The facility, registered as an OTC drug product manufacturer, was found to have significant Current Good Manufacturing Practice (CGMP) violations, rendering its drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Failure to verify component identity (21 CFR 211.84(d)(1))**: The firm did not adequately test incoming components, such as ethanol, for identity, lacking scientific evidence of raw material conformity. 2. **Failure to establish written production and process control procedures (21 CFR 211.100(a))**: Manufacturing processes were not demonstrated to be reproducible or controlled, with incomplete process validation reports. Products were distributed to U.S. markets prior to performing process validations, and the Quality Unit failed to ensure validation before release. 3. **Failure to conduct final product testing (21 CFR 211.165(a))**: The firm did not demonstrate adequate finished drug product testing, including identity and strength of active ingredients, prior to release.

The FDA recommends engaging a qualified CGMP consultant to perform a comprehensive six-system