Drug factory · FDA FEI 3005987757
Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen)
Mooswiesen 2, Ravensburg, Germany
Problems found, fixed voluntarily at FDA's last inspection, Jul 21, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
8 drug inspections on record since 2010: 4 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 21, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 20, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 12, 2018 | No problems found | Drug Quality Assurance | — |
| Jul 26, 2016 | No problems found | Drug Quality Assurance | — |
| Dec 5, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Oct 28, 2013 | No problems found | Drug Quality Assurance | — |
| Jul 20, 2012 | No problems found | Drug Quality Assurance | — |
| Apr 1, 2010 | Problems found, fixed voluntarily | 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.
Dec 5, 2014 inspection
- Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Registered with FDA for: analysis; label; manufacture; pack.