Drug factory · FDA FEI 3007256671
Siegfried Malta Limited
HHF070 Hal Far Industrial Estate, Hal Far, Malta
Problems found, fixed voluntarily at FDA's last inspection, Sep 14, 2023.
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 2020: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Solriamfetol | Makes it | Axsome Therapeutics, Inc. | 81968-350, 81968-351 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 14, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 29, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack.