483
Janssen Biologics B.V.FDA 483 - Janssen Biologics B.V.
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Record Details
An FDA inspection of Janssen Biologics B.V. in Sassenheim, The Netherlands, identified a systemic failure in the firm's manufacturing operations. The company did not consistently adhere to its own established procedure for initiating investigations into nonconformances. This indicates a significant issue with procedural compliance within their quality system.
- Company
- Janssen Biologics B.V.
- Product Type
- Biologics
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ID · 9559ba82-0b04-44ff-aefd-5c27de571195