Drug factory · FDA FEI 3002807078
Glaxo Operations UK Ltd
Harmire Road, Barnard Castle, United Kingdom
Problems found, fixed voluntarily at FDA's last inspection, Feb 10, 2023.
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 2008: 1 with no problems, 7 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Tapinarof | Makes it, tests it and packages it | Organon LLC | 81672-5051 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 10, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 2, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 23, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 9, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 22, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 1, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 22, 2009 | No problems found | Drug Quality Assurance | — |
| Dec 18, 2008 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack; sterilize.