# FDA 483 - Barr Laboratories Inc. - Unknown Date

Source: https://www.keypedia.com/records/483/barr-laboratories-inc/e293af5c-de58-4574-b3d6-25bc0cd3594d

> FDA 483 for Barr Laboratories Inc. on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Barr Laboratories Inc.
- Product Type: biologics
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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.

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## Related Officers

- [Fabian Chaparro](https://www.keypedia.com/people/fabian-chaparro/471bab27-aef3-4a9f-9269-afee4f780fe4)
- [National Expert, Pharmaceutical](https://www.keypedia.com/people/simone-e-pitts/e405f1fc-4aff-4202-b216-ddbdc342d108)

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

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1