# FDA 483 - Biotest Pharmaceuticals Inc. - November 08, 2026

Source: https://www.globalkeysolutions.net/records/483/biotest-pharmaceuticals-inc/7db8f517-cb81-4ca8-b5fe-1cc168b11251

> FDA 483 for Biotest Pharmaceuticals Inc. on November 08, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biotest Pharmaceuticals Inc.
- Inspection Date: 2026-11-08
- Product Type: biologics
- Office Name: Center for Veterinary Medicine
- Summary: An FDA inspection of Biotest Pharmaceuticals Inc. in Boca Raton, Florida, a licensed biological manufacturer, revealed significant deficiencies across its quality, production, and laboratory systems. Observations included inadequate investigations of product particles, release of products without resolving deviations, and failures in environmental monitoring and facility maintenance. The firm also demonstrated issues with validation practices, change control, and laboratory data integrity related to its Nabi-HB product.

## Related Officers

- [Michael C. Kennedy](https://www.globalkeysolutions.net/people/michael-c-kennedy/3bff77b0-1901-4294-badc-754a94983a13)
- [Mihaly L. Igmody](https://www.globalkeysolutions.net/people/mihaly-l-igmody/0f0bc9e5-ebd1-4ba6-af17-53afb278b5eb)
- [Program Expert for Advanced Manufacturing ](https://www.globalkeysolutions.net/people/prabhu-p-raju/2c0aaede-fe16-4431-bc21-614d7f18cb32)

Company: https://www.globalkeysolutions.net/companies/biotest-pharmaceuticals-inc/4784779c-5dc1-4dfe-8448-83f20e3b6126

Office: https://www.globalkeysolutions.net/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4