FDA WARNING_LETTER - Wuxi Medical lnstrument Factory Co., Ltd. - November 15, 2024

The FDA inspected Wuxi Medical Instrument Factory Co., Ltd. in China from November 11-15, 2024, identifying significant Current Good Manufacturing Practice (CGMP) violations. The facility's drug products are deemed adulterated under sections 501(a)(2)(A) and 501(a)(2)(B) of the FD&C Act due to insanitary conditions and non-conformance to CGMP.

The FDA found the facility in disrepair, poorly cleaned, and maintained. Specific violations include: 1. Failure to establish and follow procedures to prevent microbiological contamination of sterile drug products, including validation of sterilization processes (21 CFR 211.113(b)). The firm discontinued a sterilization method without implementing a new one, lacked environmental monitoring, and failed to ensure proper operator gowning. 2. Failure to conduct appropriate laboratory testing for sterility on purportedly sterile drug products (21 CFR 211.167(a)). The firm manufactured and distributed a "sterile" product without performing sterility testing. 3. Failure to test samples of each component for identity and conformity to specifications, and to validate supplier test analyses (21 CFR 211.84(d)(1) and 211.84(d)(2)). The firm relied solely on COAs for incoming materials and failed to test its water system. 4