# FDA 483 - Vetter Pharma Fertigung GmbH & Co. KG - May 13, 2026

Source: https://www.keypedia.com/records/483/vetter-pharma-fertigung-gmbh-co-kg/558703ee-5908-4eb9-b88e-53f9d6102875

> FDA 483 for Vetter Pharma Fertigung GmbH & Co. KG on May 13, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vetter Pharma Fertigung GmbH & Co. KG
- Inspection Date: 2026-05-13
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Vetter Pharma Fertigung GmbH & Co. KG, a licensed biological manufacturer in Ravensburg, Germany, identified significant deficiencies in batch production and control records, as well as laboratory records. The firm failed to maintain complete information for batch production, including the disposition status of unreconciled syringes, and lacked proper documentation in laboratory records as specified by their own SOPs. These issues indicate a lack of adequate control over manufacturing and quality processes.

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## Related Officers

- [Program Expert for Advanced Manufacturing ](https://www.keypedia.com/people/prabhu-p-raju/2c0aaede-fe16-4431-bc21-614d7f18cb32)
- [investigator](https://www.keypedia.com/people/mizanne-e-lewis/c79964ac-5163-44a2-89e9-8cc8775de9b4)

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

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