# FDA 483 - Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) - March 19, 2024

Source: https://www.keypedia.com/records/483/vetter-pharma-fertigung-gmbh-co-kg-ravensburg-mooswiesen/c31ab762-fcfa-4474-81f2-45fc2d77b570

> FDA 483 for Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) on March 19, 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 (Ravensburg Mooswiesen)
- Inspection Date: 2024-03-19
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Vetter Pharma-Fertigung GmbH & Co. KG, a sterile drug product manufacturer in Ravensburg, Germany, was cited for four observations during an FDA inspection. The observations primarily concern deficiencies in preventing microbiological contamination, inadequate identity testing procedures for labeled products, a deficient visual inspection program, and insufficient written procedures for manufacturing and testing. These issues indicate a need for improved controls in aseptic processing, quality control, and documentation practices.

## 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 - 2017-11-02](https://www.keypedia.com/records/483/vetter-pharma-fertigung-gmbh-co-kg-ravensburg-mooswiesen/2258d7a5-a03c-41c2-802b-a49027241434)
- [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)

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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