Drug factory · FDA FEI 3014849838
Amryt GmbH
Streiflingsweg 11, Niefern-Öschelbronn, Germany
Problems found, fixed voluntarily at FDA's last inspection, Dec 6, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
1 drug inspection on record since 2022: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Birch Triterpenes | Makes the active ingredient, tests it, packages it and labels it | Amryt Pharmaceuticals Designated Activity Company, Chiesi USA, Inc. | 76431-310, 10122-310 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 6, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; label; pack.