FDA 483 - Takeda Pharmaceutical Company Limited - November 01, 2023

Takeda Pharmaceutical Company Limited in Hikari, Japan, was cited with a Form FDA 483 for multiple quality control deficiencies during an inspection. Observations included a lack of comprehensive investigations into critical quality complaints for Lupron Depot, insufficient review of product discrepancies, and inadequate environmental monitoring in aseptic processing areas. Additionally, the firm failed to perform appropriate laboratory testing for objectionable microorganisms on drug product batches.