Baxalta US Incorporated – FDA 483, May 31, 2023

Baxalta US Inc. (Takeda) in Los Angeles, CA, a licensed biological products manufacturer, was cited for significant deficiencies during an FDA inspection. The observations highlight severe issues in manufacturing deviation and OOS investigations, inadequate documentation practices, unsanitary facility conditions, and critical failures in QC microbiology testing and product labeling. These issues indicate a broad lack of control over product quality and safety.