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483
•Barr Laboratories Inc.

Barr Laboratories Inc. – FDA 483

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
Office
Office of Biological Products Operations - Division I
People
  • Fabian Chaparro
  • Simone E. Pitts (National Expert, Pharmaceutical)
View Company Profile

ID · e293af5c-de58-4574-b3d6-25bc0cd3594d

Other documents for Barr Laboratories Inc.
  • 483 - 2025-05-09May 9, 2025
  • 483 - 2022-11-04November 4, 2022
  • 483 - 2017-04-14April 14, 2017

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