# FDA 483 - Vetter Pharma Fertigung GmbH & Co. KG - January 09, 2017

Source: https://www.keypedia.com/records/483/vetter-pharma-fertigung-gmbh-co-kg/018e604e-9dc9-4387-a0cc-53b35d09cf36

> FDA 483 for Vetter Pharma Fertigung GmbH & Co. KG on January 09, 2017. 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: 2017-01-09
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: Vetter Pharma Fertigung Gmbh & Co. KG. in Ravensburg, Germany, a sterile drug manufacturer, was cited for significant deficiencies during an FDA inspection. Observations included incomplete complaint investigations, non-standardized sampling procedures, lack of identity testing for incoming APIs, and inadequate audit trails for computer systems. Additionally, the firm lacked assurance of ISO-5 classification maintenance during sterility testing.

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## Related Officers

- [Compliance Officer / Investigator](https://www.keypedia.com/people/erika-v-butler/3e654530-4c29-403d-880e-a5422315c3c0)

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

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