FDA WARNING_LETTER - Hangzhou Huiji Biotechnology Co., Ltd. - November 18, 2024

The FDA issued a Warning Letter to Hangzhou Huiji Biotechnology Co., Ltd. following a review of records submitted in response to a 704(a)(4) request. The facility, a manufacturer of OTC drug products, was found to have significant Current Good Manufacturing Practice (CGMP) violations, rendering its drug products adulterated under section 501(a)(2)(B) of the FD&C Act. Key deficiencies include the firm's failure to conduct identity testing for each drug component (21 CFR 211.84(d)(1)), specifically for glycerin (to detect DEG/EG) and ethanol (to detect methanol), which are high-risk ingredients. Additionally, the firm failed to perform appropriate laboratory determinations of satisfactory conformance to final specifications for finished drug products, including the identity and strength of active ingredients like ethanol, prior to release (21 CFR 211.165(a)). The Quality Control Unit was also deemed inadequate, failing to effectively oversee manufacturing operations, batch records, stability data, and water system monitoring (21 CFR 211.22(a)). The FDA recommends engaging a qualified CGMP consultant to evaluate operations and perform a comprehensive six-system audit. As a result, the firm was placed on Import Alert 66-40, and failure to correct violations may lead to refusal of admission of products into the U.S. and withholding of new application approvals. A written response detailing corrective actions is required within 15 working days.