Drug factory · FDA FEI 3002853327
Lichtenheldt GmbH Pharmazeutische Fabrik
Industriestr. 7 11, Wahlstedt, Germany
Problems found, fixed voluntarily at FDA's last inspection, Feb 17, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections 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 it, 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 |
|---|---|---|---|
| Feb 17, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 17, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack.