Drug factory · FDA FEI 3008345811
GP Pharm S.a.u.
POLIGONO INDUSTRIAL ELS VINYETS-FOGARS (SECTOR II), CR C-244 KM 22, Sant Quinti De Mediona, Spain
Problems found, fixed voluntarily at FDA's last inspection, Sep 21, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2015: 0 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Leuprolide | Makes it | Cipla USA., Inc. | 69097-909 |
| Lurbinectedin | Makes it | Jazz Pharmaceuticals, Inc. | 68727-712 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 21, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 2, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 27, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack; sterilize.