# FDA 483 - Barr Laboratories Inc. - May 09, 2025

Source: https://www.keypedia.com/records/483/barr-laboratories-inc/c0dc6647-bb49-4ee8-83b6-95a22557254b

> FDA 483 for Barr Laboratories Inc. on May 09, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Barr Laboratories Inc.
- Inspection Date: 2025-05-09
- Product Type: biologics
- Office Name: Baltimore District Office
- Summary: 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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## Related Officers

- [Scott T. Ballard](https://www.keypedia.com/people/scott-t-ballard/09b2ae9a-3b30-45bd-bac1-437365e938da)

Company: https://www.keypedia.com/companies/barr-laboratories-inc/c462b6c3-5357-4446-9aad-53dd2b49b1ce

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa