Drug factory · FDA FEI 3010680503
INDIVIOR UK Limited
Hull, United Kingdom
Matched to FDA's records by company name, because this plant's registration on the label has expired.
Problems found, fixed voluntarily at FDA's last inspection, Sep 13, 2021.
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 2017: 1 with no problems, 1 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 |
| Buprenorphine and Naloxone | Makes the active ingredient and tests it | Indivior Inc. | 12496-1202, 12496-1204, 12496-1208 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 13, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 7, 2017 | No problems found | Drug Quality Assurance | — |