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Nantong Furuida Packaging Products Co., Ltd., an OTC drug manufacturer in China, failed to conduct required testing of active pharmaceutical ingredients (APIs) for identity and conformity with specifications for purity, strength, and quality as mandated by CGMP regulations. The company released APIs for manufacturing based solely on supplier certificates of analysis without qualifying suppliers or verifying the information provided, and did not demonstrate testing of incoming raw material lots, including methanol testing for isopropyl alcohol. These manufacturing and control failures rendered the firm's drug products adulterated under federal law.