483
Barr Laboratories Inc.FDA 483 - Barr Laboratories Inc.
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Record Details
Barr Laboratories, Inc. in Forest, VA, was inspected from February 21-28, 2018, and received one observation. The inspection revealed inadequate qualification of the lyophilization process for Adenovirus Type 4 and 7, which was a repeat observation from a previous inspection. This indicates a persistent issue with production and process controls.
- Company
- Barr Laboratories Inc.
- Product Type
- Biologics
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ID · e293af5c-de58-4574-b3d6-25bc0cd3594d