FDA 483 - Shanghai Henlius Biologics Co., Ltd. Songjiang Site 2 - March 11, 2025
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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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