Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistAnhui Hanbon Daily Chemical Co., Ltd., a Chinese drug manufacturer, was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of over-the-counter pharmaceutical products following an FDA inspection in February 2025. The company failed to perform adequate identity testing on incoming component lots, including insufficient spectroscopic identification, chromatographic analysis, and contamination screening for key active ingredients and raw materials. These testing deficiencies resulted in the firm's drug products being deemed adulterated under federal law, as the company could not ensure its components met specifications for identity, purity, strength, and quality.