# FDA 483 - Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) - August 26, 2022

Source: https://www.keypedia.com/records/483/vetter-pharma-fertigung-gmbh-co-kg-ravensburg-mooswiesen/4ec9333d-9e7c-41d0-97ba-d92766818280

> FDA 483 for Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) on August 26, 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 (Ravensburg Mooswiesen)
- Inspection Date: 2022-08-26
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA inspected Vetter Pharma-Fertigung GmbH & Co. KG in Ravensburg, Germany, a drug product manufacturer, from August 22-26, 2022. The inspection, conducted by the Division of Biotechnology Manufacturing, resulted in three observations documented on Form FDA 483.

Observation 1 noted deficiencies in written procedures for production and process control. Specifically, the setup of a Fill Line on August 24, 2022, involved RABS into Grade A airflow and Grade B space assembly without sanitization of the RABS into Grade A space. Additionally, two deviations (759735 and 630260) from March 2022 and March 2020, respectively, concerning non-integral HEPA filters in Grade A/B space and outside RABS in Grade A airflow (Grade B space) for the Fill Line, were initially classified as minor. The product quality impact assessment for these deviations was deemed incomplete, lacking a review of product complaints and reserve samples.

Observation 2 indicated inadequate maintenance of an equipment system supporting drug product manufacture. On August 22, 2022, the Fill Line mechanical box cover in Grade A space was observed not to be sealed as designed.

Observation 3 cited a failure to follow a standard operating procedure (SOP). On August 22, 2022, numerous documentation write-overs were

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## Related Officers

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

Company: https://www.keypedia.com/companies/vetter-pharma-fertigung-gmbh-co-kg-ravensburg-mooswiesen/d0287c3d-c544-40de-aece-ba713025286c

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c