FDA 483 - Takeda GmbH, Plant Oranienburg - March 16, 2018

An FDA inspection of Takeda GmbH, Plant Oranienburg, identified significant deficiencies in the firm's investigation processes. The company failed to thoroughly investigate unexplained discrepancies, including metal contamination in drug product batches, and did not determine root causes or implement corrective actions. Additionally, customer complaint investigations for broken tablets were not expanded to include other relevant batches, leading to the commercial release of potentially affected products.