Drug factory · FDA FEI 3002806319
AMINO GmbH
An der Zucker-Raffinerie 9, Frellstedt, Germany
Problems found, fixed voluntarily at FDA's last inspection, May 9, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2011: 0 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Betaine | Makes the active ingredient | Eton Pharmaceuticals, Inc. | 71863-115 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 9, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 12, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 13, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 7, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.