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Talk to a SpecialistTalk to a SpecialistYuyao YiJia Daily Chemical Co., Ltd., a Chinese manufacturer of over-the-counter drug products including hand sanitizers, failed to conduct adequate finished product testing to verify the identity and strength of active ingredients prior to release, violating CGMP requirements under 21 CFR 211.165(a). The company's response to an FDA records request demonstrated insufficient testing documentation and missing test methods for products shipped to the United States, rendering these drug products adulterated. These manufacturing and quality control deficiencies indicated the facility's methods, facilities, and controls did not conform to current good manufacturing practice standards for finished pharmaceuticals.