Drug factory · FDA FEI 3002806936
Esteve Quimica, S.A.
Caracas 17-19, Barcelona, Spain
Problems found, fixed voluntarily at FDA's last inspection, Jun 22, 2018.
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 2012: 2 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Neratinib | Tests it | Puma Biotechnology, Inc. | 70437-240 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 22, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 18, 2015 | No problems found | Drug Quality Assurance | — |
| Jun 21, 2012 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis.