Drug factory · FDA FEI 3002270322
Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse)
Schuetzenstrasse 87, Ravensburg, Germany
Problems found, fixed voluntarily at FDA's last inspection, Jul 13, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
10 drug inspections on record since 2010: 2 with no problems, 8 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 13, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 11, 2019 | No problems found | Drug Quality Assurance | — |
| Jan 17, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 20, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 29, 2014 | No problems found | Drug Quality Assurance | — |
| Dec 5, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Nov 9, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 17, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 1, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 28, 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, 2013 inspection
- Lack of or inadequate procedures 21 CFR 820.100(a)
Procedures for corrective and preventive action have not been adequately established.
Registered with FDA for: analysis; manufacture.