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

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.