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

Source: https://www.globalkeysolutions.net/records/483/vetter-pharma-fertigung-gmbh-co-kg-ravensburg-helmut-vetter-strasse/a4a9b235-9439-493f-8413-348ec4ef110c

> FDA 483 for Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Helmut-Vetter-Strasse) 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 Helmut-Vetter-Strasse)
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Vetter PharmaFertigung GmbH&Co KG in Ravensburg, Germany, a drug warehouse and sterile drug product visual inspection site, revealed multiple significant deficiencies. Observations included inadequate quality control unit procedures, incomplete drug complaint investigations, insufficient GMP training, and lacking written procedures for sampling and equipment qualification. Additionally, issues were noted with uncontrolled access to labeling materials and unsanitary conditions in storage areas.

## Related Documents

- [483 - 2019-04-11](https://www.globalkeysolutions.net/records/483/vetter-pharma-fertigung-gmbh-co-kg-ravensburg-helmut-vetter-strasse/6fbd8de5-6dc1-4b7a-816d-b2433cdfce47)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/noreen-muniz/0bb20d12-62ad-42aa-8b0a-c44b339d413f)

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/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd