FDA 483 - Takeda Manufacturing Austria AG - June 13, 2022

Takeda Manufacturing Austria AG, a licensed biological manufacturer in Vienna, Austria, received a Form 483 for significant deficiencies observed during an FDA inspection. The firm was cited for inadequate investigations into unexplained discrepancies and batch failures, including a lack of effectiveness checks for corrective actions. Additionally, the inspection revealed failures to follow procedures designed to prevent microbiological contamination of sterile drug products and non-adherence to written sampling and testing plans.