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Chengdu Innovation Pharmaceutical Co., Ltd., a Chinese active pharmaceutical ingredient (API) manufacturer, failed to comply with Current Good Manufacturing Practice (CGMP) standards, resulting in adulterated drug products distributed to the United States. The facility did not perform identity testing on incoming production materials prior to release for manufacturing use, creating a significant gap in quality assurance and material verification. This critical deviation prevented the company from demonstrating that incoming materials met appropriate specifications before being incorporated into drug manufacturing processes.