FDA EIR - Zhejiang Huahai Pharmaceutical Co., Ltd. - June 14, 2017

This FDA Pre-Approval Inspection of Zhejiang Huahai Pharmaceutical Co., Ltd. in Taizhou, China, occurred from June 5 to June 14, 2017. The inspection evaluated the firm's manufacturing of finished drug products under the Current Good Manufacturing Practices (CGMPs) framework, specifically focusing on readiness for commercial manufacturing, conformance to application, and data integrity as part of a pre-approval process for a new tablet product. While the inspection concluded with a "No Action Indicated" (NAI) classification and no FDA Form 483 was issued, two significant verbal observations were discussed with management. Firstly, several Corrective and Preventive Actions (CAPAs) were found to be open for approximately three years without a scheduled completion date, including one from April 2013 related to product sticking to equipment. The firm committed to evaluating existing data to address this long-standing issue. Secondly, the cleaning validation procedures did not adequately establish the maximum number of batches of the same product that could be manufactured before equipment cleaning was required to prevent excessive carryover. The firm agreed to develop and document this critical information for all products. Despite these observations, the inspection recommended approval for the application product.