483
Sanofi Pasteur Inc.FDA 483 - Sanofi Pasteur Inc.
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Record Details
An FDA inspection of Sanofi Pasteur, Inc. in Swiftwater, PA, a vaccine manufacturer, revealed two significant observations. The firm failed to follow procedures for YF-VAX production operations, specifically regarding conveyor speed adjustments during lyophilizer unloading. Additionally, the firm did not adequately document or evaluate cycle failures associated with a specific line, with no investigation initiated to assess trends or impact on process validation.
- Company
- Sanofi Pasteur Inc.
- Product Type
- Biologics
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