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

Source: https://www.keypedia.com/records/483/takeda-manufacturing-austria-ag/7a38bbf8-b809-454c-a080-c4654ad9619a

> FDA 483 for Takeda Manufacturing Austria AG on June 13, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Takeda Manufacturing Austria AG
- Inspection Date: 2022-06-13
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [Program Expert for Advanced Manufacturing ](https://www.keypedia.com/people/prabhu-p-raju/2c0aaede-fe16-4431-bc21-614d7f18cb32)
- [Mikhail Ovanesov](https://www.keypedia.com/people/mikhail-ovanesov/5167a693-fb5c-485d-b8e9-50ce8a6bdd90)
- [Travis P. Stadler](https://www.keypedia.com/people/travis-p-stadler/d25d7464-9cc4-4810-aabe-ee13db9c167f)

Company: https://www.keypedia.com/companies/takeda-manufacturing-austria-ag/539fa431-79de-4217-805e-0e32f74178e7

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd