Drug factory · FDA FEI 3002808116
Piramal Healthcare UK Limited
Whalton Road, Morpeth, Northumberland, United Kingdom
Problems found, fixed voluntarily at FDA's last inspection, Jun 18, 2021.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2009: 3 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Bexagliflozin | Makes it | TheracosBio, LLC | 82381-2000, 82381-2174 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 18, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 21, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 13, 2017 | No problems found | Drug Quality Assurance | — |
| Oct 17, 2014 | No problems found | Drug Quality Assurance | — |
| Nov 20, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 9, 2009 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; label; manufacture; pack.