Drug factory · FDA FEI 3008798339
Quotient Sciences (alnwick) Limited
TAYLOR DRIVE, Alnwick, United Kingdom
Problems found, fixed voluntarily at FDA's last inspection, Aug 29, 2024.
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 2015: 2 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Buprenorphine | Tests it | Indivior Inc. | 12496-0100, 12496-0300 |
| Buprenorphine and Naloxone | Tests it | Indivior Inc. | 12496-1202, 12496-1204, 12496-1208 +1 |
| Gadolinium Cation (3+) | Tests it | GE Healthcare Inc. | 0407-1066 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 29, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 28, 2023 | No problems found | Bioresearch Monitoring | — |
| Jun 21, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 14, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 10, 2015 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis.