483
Barr Laboratories Inc.FDA 483 - Barr Laboratories Inc. - May 09, 2025
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Record Details
Barr Laboratories Inc. in Forest, VA, a vaccine manufacturer, received three observations during an FDA inspection. The firm failed to establish adequate written procedures for evaluating batch records and trending quantitative data. Additionally, test methods were not properly drafted or standardized, and written procedures for personnel entry into manufacturing areas were found to be insufficient.
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