FDA 483 - Yangzhou H&R Plastic Daily Chemical Co., Ltd. - October 24, 2025

An FDA inspection of Yangzhou H&R Plastic Daily Chemical Co., Ltd. in Yangzhou, China, revealed significant deficiencies across its OTC drug manufacturing operations. The firm failed to implement adequate quality control unit procedures, process validation, raw material identity testing, labeling controls, laboratory controls, and equipment cleaning and maintenance. These issues indicate a systemic lack of adherence to current good manufacturing practices, posing risks to drug product quality and purity.