Drug factory · FDA FEI 3004058183
BioChem Labor für biologische und chemische Analytik GmbH
Daimlerstr. 5b, Karlsruhe, Germany
No problems found at FDA's last inspection, Mar 23, 2022.
No Action Indicated: inspectors found no objectionable conditions.
4 drug inspections on record since 2013: 3 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Birch Triterpenes | Tests it | Amryt Pharmaceuticals Designated Activity Company, Chiesi USA, Inc. | 76431-310, 10122-310 |
| Gadolinium Cation (3+) | Tests it | Bracco Diagnostics Inc. | 0270-5164, 0270-5264 |
| Gadoteridol | Tests it | Bracco Diagnostics Inc. | 0270-1111 |
| Iomeprol | Tests it | BIPSO GmbH, Bracco Diagnostics Inc. | 76381-725, 76381-730, 76381-735 +13 |
| Iopamidol | Tests it | Bracco Diagnostics Inc. | 0270-1314, 0270-1315, 0270-1316 +3 |
| Motixafortide | Tests it | BioLineRx USA Inc, Gamida Cell Inc. | 82737-073, 73441-062 |
| Oteseconazole | Tests it | Mycovia Pharmaceuticals, Inc. | 74695-823 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 23, 2022 | No problems found | Drug Quality Assurance | — |
| Nov 7, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Jan 19, 2016 | No problems found | Drug Quality Assurance | — |
| Jun 6, 2013 | 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.
Nov 7, 2017 inspection
- Following/documenting laboratory controls 21 CFR 211.160(a)
Established test procedures and laboratory control mechanisms are not followed and documented at the time of performance.
Registered with FDA for: analysis.