FDA 483 - Zhejiang Huahai Pharmaceutical Co., Ltd. - November 18, 2016

FDA investigators conducted an inspection of Zhejiang Huahai Pharmaceutical Co. Ltd. in Taizhou, China, concluding on November 18, 2016. The inspection revealed significant deviations from Current Good Manufacturing Practice (CGMP) regulations, specifically concerning the quality control unit and manufacturing processes.

A key observation was the failure of the quality control unit to ensure that drug products met all required specifications for identity, strength, quality, and purity. This was evidenced by the company's release of Valsartan Active Pharmaceutical Ingredient (API) batches containing an impurity, N-Nitrosodimethylamine (NDMA), at levels exceeding the acceptable limit of 0.3 ppm. The firm's internal investigation identified the source of NDMA as a side reaction during the manufacturing process, yet batches containing this impurity were released for distribution.

Furthermore, the firm's quality control unit failed to establish adequate written procedures for the review of unapproved raw material batches. This deficiency allowed for the use of raw materials that did not meet specifications, contributing to the impurity issue in the final API. The inspection highlighted a systemic failure in the quality control unit's oversight and a lack of robust procedures to prevent the release of adulterated drug products. These findings indicate a critical deficiency in the company's quality system, potentially impacting the safety and efficacy of their drug products.