Drug factory · FDA FEI 3010166293
Eurofins BioPharma Product Testing Hamburg GmbH
Am Neuländer Gewerbepark 2, Hamburg, Germany
Problems found, fixed voluntarily at FDA's last inspection, Oct 19, 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 2013: 2 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 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 19, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 18, 2019 | No problems found | Drug Quality Assurance | — |
| Jul 10, 2013 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis.