FDA 483 - Zhejiang Huahai Pharmaceutical - November 12, 2024

Zhejiang Huahai Pharmaceutical Co., Ltd., an API manufacturer in Linhai, China, was cited for significant deficiencies across its quality control, production, and documentation systems. The inspection revealed a pervasive lack of data integrity, inadequate laboratory and deviation investigations, and poor equipment maintenance, all of which compromise the reliability of test results and the quality of APIs for the U.S. market. These issues indicate a systemic failure in maintaining GMP compliance.