Drug factory · FDA FEI 3002806712
Labcorp Early Development Laboratories Limited
Otley Rd, Harrogate, United Kingdom
Problems found, fixed voluntarily at FDA's last inspection, Mar 9, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
8 drug inspections on record since 2009: 6 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Amikacin | Tests it | Insmed Incorporated | 71558-590 |
| Apomorphine | Tests it | MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc. | 27505-004 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 9, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 27, 2019 | No problems found | Bioresearch Monitoring | — |
| Jun 15, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 14, 2014 | No problems found | Drug Quality Assurance | — |
| Feb 22, 2013 | No problems found | Bioresearch Monitoring | — |
| Sep 12, 2012 | No problems found | Drug Quality Assurance | — |
| Jul 15, 2011 | No problems found | Drug Quality Assurance | — |
| Jun 5, 2009 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis.