Biotest AG – FDA 483

Biotest AG in Dreieich, Germany, was inspected by the FDA from December 4-15, 2023, regarding its drug substance and drug product manufacturing. The inspection revealed significant deficiencies in quality oversight, deviation management, process validation, environmental controls, and documentation practices for the Yimmugo drug product. These issues indicate a lack of adequate controls to ensure product identity, strength, quality, and purity.