# FDA 483 - Teva Biotech GmbH - March 13, 2025

Source: https://www.keypedia.com/records/483/teva-biotech-gmbh/c32721c7-3cb1-4441-979b-735e8d352d8e

> FDA 483 for Teva Biotech GmbH on March 13, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Teva Biotech GmbH
- Inspection Date: 2025-03-13
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Teva Biotech GmbH in Ulm, Germany, a drug substance manufacturer, was cited for significant deficiencies across its manufacturing processes, laboratory controls, and facility maintenance. The inspection revealed issues with process validation, facility design, data integrity, adherence to and adequacy of procedures, and various qualification and validation activities. These observations indicate a broad range of concerns regarding the firm's ability to ensure the quality and integrity of its drug substance products.

## Related Officers

- [Wayne Seifert, Senior Regulatory Specialist](https://www.keypedia.com/people/wayne-seifert-senior-regulatory-specialist/7b488047-5171-4676-b3b9-0409cf1522e7)
- [issuing_officer](https://www.keypedia.com/people/ying-xin-fan/905eacc9-1394-4215-9fbc-61c151c0debe)

Company: https://www.keypedia.com/companies/teva-biotech-gmbh/9f59882c-deb9-4288-aa5e-8e387435d43d

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