# FDA 483 - Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) - November 02, 2017

Source: https://www.keypedia.com/records/483/vetter-pharma-fertigung-gmbh-co-kg-ravensburg-mooswiesen/2258d7a5-a03c-41c2-802b-a49027241434

> FDA 483 for Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) on November 02, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen)
- Inspection Date: 2017-11-02
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Vetter Pharma-Fertigung GmbH & Co. KG in Ravensburg, Germany, received an FDA Form 483 citing multiple deficiencies during an inspection. Observations included inadequate procedures for preventing microbial contamination of sterile products and a failure to thoroughly review unexplained discrepancies, such as persistent microbial recovery and conflicting cleaning re-qualification results. Additionally, the firm was cited for prematurely releasing starting materials and for not restricting access to labeling storage areas to authorized personnel.

## Related Documents

- [EIR - 2016-07-16](https://www.keypedia.com/records/eir/vetter-pharma-fertigung-gmbh-co-kg-ravensburg-mooswiesen/e66fe6dd-a734-4bbc-8eee-ce519a8779a3)
- [483 - 2018-02-09](https://www.keypedia.com/records/483/vetter-pharma-fertigung-gmbh-co-kg-ravensburg-mooswiesen/d2c2a04a-70fd-47d0-9898-d4c6ae6f5b44)
- [483 - Unknown Date](https://www.keypedia.com/records/483/vetter-pharma-fertigung-gmbh-co-kg-ravensburg-mooswiesen/d970a219-8649-4511-b4c9-de455872dea0)
- [483 - 2022-08-26](https://www.keypedia.com/records/483/vetter-pharma-fertigung-gmbh-co-kg-ravensburg-mooswiesen/b7363b3b-9f74-4b28-beed-5e9a49563aa1)
- [483 - 2022-08-26](https://www.keypedia.com/records/483/vetter-pharma-fertigung-gmbh-co-kg-ravensburg-mooswiesen/6628c034-41a7-42b2-bf5a-9f3573275544)

## Related Officers

- [National Expert, Pharmaceutical](https://www.keypedia.com/people/simone-e-pitts/e405f1fc-4aff-4202-b216-ddbdc342d108)
- [CSO](https://www.keypedia.com/people/mihaly-s-ligmond/2904ef70-a757-49c7-9ac4-a2c07ee36001)

Company: https://www.keypedia.com/companies/vetter-pharma-fertigung-gmbh-co-kg-ravensburg-mooswiesen/d0287c3d-c544-40de-aece-ba713025286c

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