Takeda Pharmaceutical Company Limited – FDA 483, May 24, 2023

Takeda Pharmaceutical Company Limited in Hikari, Japan, was cited for multiple deficiencies during an FDA inspection related to sterile drug product manufacturing. The observations primarily concern inadequate controls for preventing microbiological contamination, deficient environmental monitoring, and incomplete quality control procedures. The firm also failed to properly investigate discrepancies, maintain equipment, and update disinfectant efficacy studies.