Takeda Manufacturing Austria AGJune 13, 2022

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

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Record Details

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.

Company: Takeda Manufacturing Austria AG
Inspection Date: June 13, 2022
Product Type: Biologics
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
People: Mikhail Ovanesov
Travis P. Stadler
Prabhu P. Raju (Program Expert for Advanced Manufacturing )

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ID · 7a38bbf8-b809-454c-a080-c4654ad9619a