FDA 483 - Biotest AG

Biotest AG in Dreieich, Germany, was inspected by the FDA from December 4-15, 2023, regarding its drug substance and drug product manufacturing, specifically for Yimmugo. The inspection revealed significant deficiencies across multiple areas, including inadequate quality oversight, poor deviation management, insufficient contamination controls, and deficient process validation. These issues indicate a lack of robust control over manufacturing processes and documentation, potentially impacting product quality and purity.