# FDA 483 - Vetter Pharma Fertigung GmbH & Co. KG - April 24, 2024

Source: https://www.keypedia.com/records/483/vetter-pharma-fertigung-gmbh-co-kg/f7bee0de-fc90-415f-b6d8-541427e248c0

> FDA 483 for Vetter Pharma Fertigung GmbH & Co. KG on April 24, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vetter Pharma Fertigung GmbH & Co. KG
- Inspection Date: 2024-04-24
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Vetter Pharma-Fertigung GmbH & Co. KG in Langenargen, Germany, a sterile drug product manufacturer, revealed significant deficiencies. Observations included failures to prevent microbiological contamination during aseptic filling, an inadequate visual inspection program that repeatedly failed to remove defective products, and deficient environmental monitoring in aseptic processing areas. These issues raise concerns about the sterility assurance and quality control of their sterile drug products.

## Related Documents

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- [483 - 2026-11-02](https://www.keypedia.com/records/483/vetter-pharma-fertigung-gmbh-co-kg/58a47cca-e9e3-4e53-8f4a-ae3cc5f6d64b)

## Related Officers

- [Pharmaceutical Scientist](https://www.keypedia.com/people/andrea-franco/96b35431-a713-48a5-9a47-e160cc650730)
- [Bo Chi](https://www.keypedia.com/people/bo-chi/9c83477d-58c1-4183-832e-ce8cbd25a521)

Company: https://www.keypedia.com/companies/vetter-pharma-fertigung-gmbh-co-kg/9c78f7c1-8016-4128-9dc3-ce5b4e0e0d44

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