The FDA has released its observations following an inspection of China-based Jiangsu Hengrui Pharmaceuticals, during which the agency identified significant issues.
The inspection, conducted between January 8-16, 2024, revealed several critical compliance issues at the company's facility in Lianyungang, Jiangsu, China. The FDA identified significant lapses in microbiological contamination control procedures, inadequate validation of aseptic processing, and discrepancies in recorded intervention times during production.
The agency also found that container closure integrity tests were insufficient, using empty vials instead of filled ones and lacking necessary controls. Cleaning procedures for equipment and utensils were also found to be inadequate, with contaminants not properly considered and insufficient swab sampling methods.
Further issues were found with the quality control unit, which failed to manage and approve critical documents properly. Moreover, records related to drug product production were not readily available during the inspection, causing significant delays. The computerized systems used in the facility did not comply with 21 CFR Part 11, lacking essential audit trails and data management capabilities.
Facility maintenance was another area of concern, with water leaks and mold growth in storage areas potentially compromising drug product safety. The parenteral drug product workshop also lacked hot and cold water in handwashing stations.
Hengrui Pharmaceuticals is a major Chinese pharmaceuticall manufacturer established in 1970. The company specializes in the development, production, and marketing of a wide range of pharmaceutical products, including oncology, anesthesia, and pain management medications.