Drug factory · FDA FEI 3002806533
Butterworth Laboratories Ltd
54 56 Waldegrave Road, Teddington, United Kingdom
Problems found, fixed voluntarily at FDA's last inspection, Apr 26, 2023.
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 2009: 3 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Buprenorphine and Naloxone | Tests it | Indivior Inc. | 12496-1202, 12496-1204, 12496-1208 +1 |
| Selexipag | Tests it | Actelion Pharmaceuticals US, Inc. | 66215-602, 66215-604, 66215-606 +8 |
| Uridine | Tests it | BTG International Inc. | 50633-220, 50633-330 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 26, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 9, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 31, 2015 | No problems found | Drug Quality Assurance | — |
| Dec 5, 2012 | No problems found | Drug Quality Assurance | — |
| Jun 2, 2009 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis.