Drug factory · FDA FEI 3002807062
HVL Pharma UK Limited
37 Hollands Road, Haverhill, United Kingdom
Problems found, fixed voluntarily at FDA's last inspection, Nov 3, 2022.
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 2008: 2 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Alemtuzumab | Packages it and labels it | Genzyme Corporation | 58468-0200, 58468-0357 |
| Mipomersen | Tests it, packages it and labels it | Kastle Therapeutics, LLC | 70688-0502 |
| Sevelamer | Makes the active ingredient and tests it | Genzyme Corporation, Sanofi-Aventis U.S. LLC | 58468-0130, 58468-0131, 58468-0132 +4 |
| Vandetanib | Packages it and labels it | Genzyme Corporation | 58468-7820, 58468-7840 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 3, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 22, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 6, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 27, 2015 | No problems found | Drug Quality Assurance | — |
| Apr 13, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 13, 2008 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; label; pack; relabel; repack.