FDA EIR - Zhejiang Haisen Pharmaceutical Co., Ltd. - April 21, 2017

An FDA inspection of Zhejiang Haisen Pharmaceutical Co., Ltd., an Active Pharmaceutical Ingredient (API) manufacturer in Dongyang city, Zhejiang, China, was conducted from April 17 to April 21, 2017. This comprehensive Good Manufacturing Practice (GMP) inspection and Pre-Approval Inspection (PAI) for a new veterinary API was performed under regulatory frameworks including Compliance Program 7356.002F for API inspections and Q7A Good Manufacturing Practice Guidance. The inspection resulted in seven observations documented on a Form FDA 483. Main issues included the failure to follow written production and process control procedures, inadequate sampling criteria for material testing, and deficiencies in batch production records, specifically regarding missing issuance signatures and incomplete documentation of significant manufacturing steps. Additionally, the company lacked established procedures, such as the use of positive controls in the microbiology laboratory, to prevent objectionable microorganisms in non-sterile drug products. The quality unit's review process was found to be insufficient in ensuring data integrity before batch release, and laboratory records were not adequately protected against deletion or modification. Zhejiang Haisen Pharmaceutical Co., Ltd. is required to address these deficiencies to ensure full compliance with FDA's GMP regulations.