# FDA 483 - Vetter Pharma Fertigung GmbH & Co. KG - August 19, 2022

Source: https://www.globalkeysolutions.net/records/483/vetter-pharma-fertigung-gmbh-co-kg/8e10db45-a299-4f5e-905e-47759b69f316

> FDA 483 for Vetter Pharma Fertigung GmbH & Co. KG on August 19, 2022. 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: 2022-08-19
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Vetter Pharma-Fertigung GmbH & Co. KG in Ravensburg, Germany, identified two significant observations related to drug product manufacturing. The firm was cited for inadequate maintenance of equipment and facilities, including cracks in cleanroom enclosures and unsealed interfaces. Additionally, deficiencies were noted in written procedures for production and process control, specifically concerning RABS sanitization and the investigation of non-integral HEPA filters.

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## Related Officers

- [Zonglin Hu](https://www.globalkeysolutions.net/people/zonglin-hu/fbee26bd-4f87-421c-98bc-6ee0176d7d15)
- [Senior Regulatory Specialist](https://www.globalkeysolutions.net/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)

Company: https://www.globalkeysolutions.net/companies/vetter-pharma-fertigung-gmbh-co-kg/6b51041e-37a7-4672-a7e2-c3c871d6231b

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd