Drug factory · FDA FEI 3003227179
Umforana Labor für Umweltanalytik und Auftragsforschung GmbH & Co. KG
Otto-von-Guericke Ring 5, Wiesbaden, Germany
Problems found, fixed voluntarily at FDA's last inspection, Apr 12, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2012: 1 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Indocyanine Green Acid Form and Water | Tests it | Renew Pharmaceuticals Limited | 70100-424 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 12, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 16, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
| Sep 13, 2012 | 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.
Jun 16, 2015 inspection
- Changes to Procedures Not Reviewed, Approved 21 CFR 211.100(a)
Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit and reviewed and approved by the quality control unit. - Lab controls established, including changes 21 CFR 211.160(a)
The establishment of specifications and laboratory control mechanisms including any changes thereto, are not drafted by the appropriate organizational unit and reviewed and approved by the quality control unit. - Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. - Complete test data included in records 21 CFR 211.194(a)
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. - Laboratory equipment calibration records 21 CFR 211.194(d)
Laboratory records do not include complete records of the periodic calibration of laboratory instruments.
Registered with FDA for: analysis.