Drug factory · FDA FEI 3008787649
Sterling Chemical Malta Ltd
HF51, Hal-Far Industrial Estate, Birzebbuga, Malta
Problems found, fixed voluntarily at FDA's last inspection, Sep 1, 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 2015: 1 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Abiraterone | Makes the active ingredient | Caraco Pharmaceutical Laboratories, Ltd., Catalent Pharma Solutions, LLC | 47335-401, 11014-0566 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 1, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 13, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 20, 2015 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: api manufacture.