Drug factory · FDA FEI 3009560142
Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Helmut-Vetter-Strasse)
Helmut-Vetter-Strasse 10, Ravensburg, Germany
Problems found, fixed voluntarily at FDA's last inspection, Jul 27, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2013: 2 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 27, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 16, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 11, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Sep 22, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 12, 2014 | No problems found | Drug Quality Assurance | — |
| Mar 14, 2013 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Apr 11, 2019 inspection
- Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Registered with FDA for: analysis.