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

Source: https://www.globalkeysolutions.net/records/483/takeda-gmbh-plant-oranienburg/b1d4c194-35ae-4a76-be53-87964288a843

> FDA 483 for Takeda GmbH, Plant Oranienburg on March 16, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Takeda GmbH, Plant Oranienburg
- Inspection Date: 2018-03-16
- Product Type: drugs
- Office Name: FDA District Office — Silver Springs, Maryland
- Summary: 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.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/kenneth-e-felkley/a765e932-11df-406d-ab45-5bf4ac9ff27b)

Company: https://www.globalkeysolutions.net/companies/takeda-gmbh-plant-oranienburg/c72ad117-1d9b-474a-8d1a-c4d0e81e9ba8

Office: https://www.globalkeysolutions.net/offices/fda-district-office-silver-springs-maryland/079bb75c-3759-4baa-baed-4159edd64552