Drug factory · FDA FEI 3009099058
BIPSO GmbH
Robert-Gerwig-Str. 4, Singen (Hohentwiel), Germany
Problems found, fixed voluntarily at FDA's last inspection, May 4, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2012: 3 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Gadolinium Cation (3+) | Makes it and tests it | Bracco Diagnostics Inc. | 0270-5164, 0270-5264 |
| Gadopiclenol | Makes it and tests it | Bracco Diagnostics Inc., Guerbet LLC | 0270-7015, 0270-7020, 0270-7025 +8 |
| Gadoteridol | Makes it and tests it | Bracco Diagnostics Inc. | 0270-1111 |
| Iomeprol | Makes it and tests it | BIPSO GmbH, Bracco Diagnostics Inc. | 76381-725, 76381-730, 76381-735 +13 |
| Iopamidol | Makes it and tests it | Bracco Diagnostics Inc. | 0270-1314, 0270-1315, 0270-1316 +3 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 4, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 7, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 17, 2016 | No problems found | Drug Quality Assurance | — |
| Feb 11, 2014 | No problems found | Drug Quality Assurance | — |
| May 10, 2012 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; manufacture.