# FDA 483 - Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Helmut-Vetter-Strasse) - April 11, 2019

Source: https://www.globalkeysolutions.net/records/483/vetter-pharma-fertigung-gmbh-co-kg-ravensburg-helmut-vetter-strasse/6fbd8de5-6dc1-4b7a-816d-b2433cdfce47

> FDA 483 for Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Helmut-Vetter-Strasse) on April 11, 2019. 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 Helmut-Vetter-Strasse)
- Inspection Date: 2019-04-11
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Vetter Pharma Fertigung GmbH & Co. KG in Ravensburg, Germany, revealed significant deficiencies in quality control and laboratory operations. The firm failed to thoroughly investigate discrepancies, ensure timely completion of investigations, and maintain adequate control over sample analysis. Additionally, the quality control unit lacked proper written procedures and agreements with contract laboratories.

## Related Documents

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## Related Officers

- [Microbiologist ](https://www.globalkeysolutions.net/people/doan-t-nguyen/2b1112b4-01b8-4581-82f2-86cbe29c8857)

Company: https://www.globalkeysolutions.net/companies/vetter-pharma-fertigung-gmbh-co-kg-ravensburg-helmut-vetter-strasse/447d2af0-9c51-4d9f-a3f4-6aee290cf97a

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1