FDA 483 - Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site) - July 16, 2026
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. received a Form FDA 483 with three observations related to manufacturing sterile drug products. The firm failed to establish adequate procedures for preventing microbiological contamination and validating sterilization processes, particularly concerning airflow visualization studies. Additionally, the quality control unit lacked proper oversight, resulting in missing records and significant errors in batch production records, and master production records were deficient in manufacturing instructions and specifications.
- Inspection Date
- July 16, 2026
- Product Type
- Drugs
ID · dcfc67cd-7925-46e3-aa1d-6a3ada69852e