FDA 483 - Zhejiang Hisun Pharmaceutical Co., Ltd. - August 11, 2017

An FDA inspection conducted from August 7 to 11, 2017, at Zhejiang Hisun Pharmaceutical Co., Ltd. in Taizhou, Zhejiang, China, identified multiple significant observations for the API/Finished Drug Product Manufacturer. The findings, detailed in an FDA 483 report, indicate areas where the company's practices deviated from regulatory expectations for quality manufacturing.

Key issues included concerns about laboratory data integrity, with incomplete records, missing audit trails for stability data, and insufficient controls for stand-alone analytical systems. Equipment cleaning and maintenance procedures were deemed deficient, lacking scientific justification for sampling points and specific instructions. The facility also failed to appropriately monitor storage conditions for stability samples, and records were not completed contemporaneously. Further observations highlighted incomplete data in microbial limit testing records, insufficient documentation for manufacturing process changes without risk assessments, and a lack of complete historical data in process validation studies. Additionally, the final API storage areas were found to be in disrepair, with observed water leakage. The company is required to thoroughly address these observations by implementing robust corrective and preventive actions to ensure compliance.