# FDA 483 - Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) - Unknown Date

Source: https://www.keypedia.com/records/483/vetter-pharma-fertigung-gmbh-co-kg-ravensburg-mooswiesen/d970a219-8649-4511-b4c9-de455872dea0

> FDA 483 for Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) on Unknown Date. 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)
- Product Type: drugs
- Office Name: Division of Advertising & Promotion 
- Summary: An FDA inspection of Vetter Pharma-Fertigung GmbH & Co. KG in Ravensburg, Germany, from July 11-17, 2019, identified significant issues with aseptic behavior and adherence to standard operating procedures. Personnel were observed not following controlled movement protocols and performing operations directly over unprotected drug product vials in Grade A/B cleanrooms. These observations indicate a failure to maintain adequate aseptic conditions during pharmaceutical production.

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## Related Officers

- [Ashley N. Queen, Ph.D., Microbiologist](https://www.keypedia.com/people/ashley-n-queen-phd-microbiologist/35cb13ab-4e08-44a5-81a5-b6155983d634)
- [Michael R. Shanks, Senior Biologist](https://www.keypedia.com/people/michael-r-shanks-senior-biologist/619295e6-cb39-4125-9a56-171774ce2cd5)

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-advertising-promotion/adcc8282-aca9-4610-955c-e6553c7619b0