Huaian Zongheng Bio-Tech Co., Ltd – FDA Warning Letter, Jul 5, 2019

The FDA inspected Huaian Zongheng Bio-Tech Co., Ltd. in China from July 1-5, 2019, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B). The firm's response to the Form FDA 483 was deemed inadequate. Key violations include failure to perform adequate final product testing for identity and strength of active ingredients prior to release (21 CFR 211.165(a)), failure to test incoming components for identity (21 CFR 211.84(d)(1)), lack of an adequate stability testing program to support assigned expiration dates (21 CFR 211.166(a)), failure to establish adequate written procedures for process control and validate manufacturing processes for all drug products (21 CFR 211.100(a)), and failure to ensure equipment, specifically the (b)(4) system, is adequately designed, controlled, and maintained for its intended use (21 CFR 211.63). The FDA also expressed concerns regarding glycerin contamination with diethylene glycol. The agency strongly recommended engaging a qualified CGMP consultant for a comprehensive audit and to evaluate corrective actions. Due to these systemic quality issues, the firm was placed on Import Alert 66-40, and FDA may withhold new drug application approvals and refuse admission of products into the U.S. The firm must provide a written response within 15 working days detailing corrective actions and timelines.