483
Shanghai Henlius Biologics Co., Ltd. Songjiang Site 2Shanghai Henlius Biologics Co., Ltd. Songjiang Site 2 – FDA 483, Mar 11, 2025
Record Details
The FDA inspected Shanghai Henlius Biologics Co., Ltd. Songjiang Site 2, a drug product manufacturer, and identified significant deficiencies. The inspection revealed inadequate process controls for sterility and product quality, inconsistent aseptic filling operations, and a lack of proper procedures to prevent microbiological contamination. Additionally, the firm's Quality Unit oversight was found to be insufficient, indicating a high risk to drug product quality and patient safety.
- Inspection date
- March 11, 2025
- Product type
- drugs
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ID · 01291a1e-07e1-4780-9fb4-911b8d032766
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