# FDA 483 - Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) - February 09, 2018

Source: https://www.keypedia.com/records/483/vetter-pharma-fertigung-gmbh-co-kg-ravensburg-mooswiesen/d2c2a04a-70fd-47d0-9898-d4c6ae6f5b44

> FDA 483 for Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) on February 09, 2018. 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: 2018-02-09
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Vetter Pharma Fertigung Gmbg & Co. KG in Ravensburg, Germany, identified a significant issue regarding the firm's risk assessment processes. Specifically, the assessment supporting media fills lacked comprehensive details and evaluations. This indicates a moderate severity finding related to quality control and manufacturing practices.

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## Related Officers

- [ Investigator, Consumer Safety Officer](https://www.keypedia.com/people/thuy-t-nguyen/1cfb5467-f0b7-49b8-85c1-00373692e35e)
- [Investigator](https://www.keypedia.com/people/michael-r-klapal/b181b5e8-4fc3-48ed-b17c-791359e7b619)

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/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8