Zhejiang Huahai Pharmaceutical – FDA EIR, May 19, 2017

The FDA conducted a pre-announced inspection of Zhejiang Huahai Pharmaceutical, located in Linhai City, China, from May 15 to May 19, 2017. This inspection, under eNSpect ID 55134, focused on the company's compliance with Good Manufacturing Practices (GMP) for active pharmaceutical ingredients (API). The inspection adhered to guidelines outlined in the Compliance Policy Guidance Manual (CPGM) 7346.832, CPGM 7356.002F, and ICH 7.

During the inspection, the FDA identified several critical issues, resulting in a Form FDA-483 being issued to Mr. Jun Du, the Executive Vice President. The main violations included inadequate controls over Quality Control instruments, failure to investigate anomalies in analytical testing, poorly maintained facilities and equipment, and insufficient scientific justification for invalidating out-of-specification results. Additionally, the firm was noted for not validating certain analytical methods and for invalidating complaints without proper documentation.

Zhejiang Huahai Pharmaceutical was required to respond in writing to the Center for Drug Evaluation and Research (CDER) within 15 days. The inspection concluded with a classification of Official Action Indicated (OAI), suggesting potential regulatory actions such as a warning letter. The firm's registration was confirmed as current, and no samples were collected during the inspection. The FDA recommended further action by the CDER's Office of Compliance to address these issues.