FDA 483 - Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Dongjin Road Site)
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Jiangsu Hengrui Pharmaceuticals CO. LTD. received a Form 483 with nine observations during an inspection from August 14-29, 2023. The observations highlight significant deficiencies across laboratory controls, aseptic processing, environmental monitoring, and batch recordkeeping, indicating a lack of robust quality systems for sterile drug product manufacturing. Issues include unrepresentative sampling, inadequate sterility testing procedures, rewritten logbook entries, turbulent airflow in aseptic areas, and insufficient contamination prevention and monitoring.
- Product Type
- Drugs
- Office
- Office of Partnerships
- Person
ID · 6a83eb5d-8c88-4934-b86a-ab09a2182318