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

Source: https://www.keypedia.com/records/483/barr-laboratories-inc/b793dc2e-2608-4d3a-83f0-ffc8d10b5f86

> 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: Office of Regulatory Affairs
- Summary: Between May 5 and May 9, 2025, the U.S. Food and Drug Administration (FDA) conducted an inspection of the Barr Laboratories Inc. vaccine manufacturing facility located in Forest, Virginia. The inspection resulted in several observations regarding the site's quality and procedural controls. Primary concerns included the firm's failure to establish written procedures for annual product reviews, specifically lacking the data trending necessary to ensure manufacturing processes remain consistent. Additionally, the investigator found that test methods were not adequately established; several procedures lacked standardized software parameters, clear techniques for quantifying ingredients, and specific endpoints for batch acceptance testing. Furthermore, the facility's protocols for personnel entering manufacturing zones were insufficient, as they did not account for the equipment or items carried by employees into sensitive processing areas. These observations were reported under the authority of the Federal Food, Drug, and Cosmetic Act to assist the company in achieving regulatory compliance. Although these findings do not represent a final Agency determination, Barr Laboratories is expected to respond to the FDA with a formal plan of corrective actions or objections to address these deficiencies. The company must ensure that its testing and entry procedures are properly drafted, reviewed, and approved to maintain the integrity of its vaccine production.

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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/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64