# FDA 483 - Vetter Pharma Fertigung GmbH & Co. KG - April 26, 2016

Source: https://www.globalkeysolutions.net/records/483/vetter-pharma-fertigung-gmbh-co-kg/6e7331c4-2eb2-4651-ac62-c3b99139d6c0

> FDA 483 for Vetter Pharma Fertigung GmbH & Co. KG on April 26, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vetter Pharma Fertigung GmbH & Co. KG
- Inspection Date: 2016-04-26
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of Vetter Pharma-Fertigung GmbH & Co. KG in Langenargen, Germany, revealed significant deficiencies in their manufacturing and quality control processes. The firm failed to justify deviations from production procedures, conducted inadequate investigations into discrepancies including glass particles in sterile products, and lacked written procedures for quality control unit responsibilities. Additionally, operators did not follow or properly document production procedures, complaint handling was deficient, and equipment calibration was not performed according to a written program.

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## Related Officers

- [Liatte Krueger](https://www.globalkeysolutions.net/people/liatte-krueger/cbfda638-7610-43d9-9301-2e010665c86d)
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Company: https://www.globalkeysolutions.net/companies/vetter-pharma-fertigung-gmbh-co-kg/9c78f7c1-8016-4128-9dc3-ce5b4e0e0d44

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321