Drug factory · FDA FEI 1000370240
Penn Pharmaceutical Services Limited
23-24 Tafarnaubach Industrial Estate, Tafarnaubach, Tredegar, United Kingdom
Problems found, fixed voluntarily at FDA's last inspection, Apr 1, 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 2010: 4 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Brigatinib | Makes it, tests it, packages it and labels it | Takeda Pharmaceuticals America, Inc. | 63020-090, 63020-113, 63020-180 +1 |
| Larotrectinib | Makes it | Loxo Oncology, Inc. | 71777-390, 71777-391, 71777-392 |
| Macitentan and Tadalafil | Makes it and tests it | Actelion Pharmaceuticals US, Inc. | 66215-812, 66215-814 |
| Nitisinone | Makes it, tests it and packages it | Cycle Pharmaceuticals Ltd. | 70709-000, 70709-002, 70709-005 +1 |
| Teriflunomide | Makes it, tests it, packages it and labels it | Genzyme Corporation | 58468-0210, 58468-0211 |
| Vandetanib | Makes it, tests it and packages it | Genzyme Corporation | 58468-7820, 58468-7840 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 1, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 1, 2019 | No problems found | Drug Quality Assurance | — |
| Jan 26, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 8, 2016 | No problems found | Drug Quality Assurance | — |
| Aug 31, 2012 | No problems found | Drug Quality Assurance | — |
| May 14, 2010 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack.