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

Source: https://www.keypedia.com/records/483/vetter-pharma-fertigung-gmbh-co-kg/ba06e707-1515-4aa8-8b60-31207fd2d199

> 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: Office of Inspections and Investigations
- Summary: An FDA inspection of Vetter Pharma-Fertigung GmbH & Co. KG in Langenargen, Germany, revealed significant deficiencies in the manufacturing of sterile drug products. The firm failed to establish and follow procedures to prevent microbiological contamination, exhibited a deficient visual inspection program unable to remove defects, and had inadequate environmental monitoring in aseptic processing areas. These issues indicate a lack of control over critical processes, posing a risk to product quality and sterility.

## Related Documents

- [483 - 2016-04-26](https://www.keypedia.com/records/483/vetter-pharma-fertigung-gmbh-co-kg/6e7331c4-2eb2-4651-ac62-c3b99139d6c0)
- [EIR - 2017-11-10](https://www.keypedia.com/records/eir/vetter-pharma-fertigung-gmbh-co-kg/55937f22-a03d-4521-818d-191375704474)
- [483 - 2017-11-02](https://www.keypedia.com/records/483/vetter-pharma-fertigung-gmbh-co-kg/58a47cca-e9e3-4e53-8f4a-ae3cc5f6d64b)
- [483 - 2024-04-24](https://www.keypedia.com/records/483/vetter-pharma-fertigung-gmbh-co-kg/f7bee0de-fc90-415f-b6d8-541427e248c0)

## 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/0016303e-704f-4a0a-ad1d-6ae4efdc1b19)

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

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8