FDA 483 - Takeda Pharmaceutical Company Limited - September 15, 2022

An FDA inspection of Takeda Pharmaceutical Company Limited in Round Lake, IL, revealed three significant observations. The firm failed to microbiologically test incoming bulk albumin for objectionable organisms, did not thoroughly review unexplained discrepancies and batch failures related to endotoxin, and exhibited deficiencies in validating supplier test results and auditing contract laboratories for critical utilities. These issues highlight concerns in quality control and supplier oversight for a licensed biological drug manufacturer.