Drug factory · FDA FEI 3003046251
NUVISAN GmbH
Im Wirrigen, Waltrop, Germany
Problems found, fixed voluntarily at FDA's last inspection, Jan 16, 2025.
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 2016: 0 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Gadoquatrane | Tests it | Bayer HealthCare Pharmaceuticals Inc. | 50419-321, 50419-322, 50419-323 +8 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 16, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 11, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 26, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
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 26, 2016 inspection
- 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. - Written procedures followed 21 CFR 211.186(a)
Procedures for the preparation of master production and control records are not described in a written procedure. - Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Registered with FDA for: analysis.