FDA 483 - Takeda Pharmaceutical Company Limited - August 09, 2019

Takeda Pharmaceutical Company Limited in Osaka, Japan, received a Form FDA 483 with four observations following an inspection from August 1-9, 2019. The firm was cited for inadequate aseptic process validation, insufficient laboratory controls for sterility assurance, incomplete laboratory records for process simulation tests, and unjustified deviations from production procedures. These issues collectively indicate deficiencies in ensuring the quality and purity of sterile drug products.