Drug factory · FDA FEI 3002806719
Sterling Pharma Solutions Limited
Sterling Place, Dudley, Cramlington, United Kingdom
Problems found, fixed voluntarily at FDA's last inspection, Jul 11, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2011: 2 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Buprenorphine | Makes the active ingredient and tests it | Indivior Inc. | 12496-0100, 12496-0300 |
| Ferric Cation | Makes the active ingredient | Shield TX (UK) Ltd | 73059-001 |
| Tazemetostat | Makes the active ingredient | Epizyme, Inc. | 72607-100 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 11, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 16, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 23, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 7, 2014 | No problems found | Drug Quality Assurance | — |
| May 12, 2011 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.