Drug factory · FDA FEI 3002807938
PROCOS SpA
Via Giacomo Matteotti 249, Cameri, Italy
Problems found, fixed voluntarily at FDA's last inspection, Sep 16, 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: 1 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Tisotumab Vedotin | Makes the active ingredient | Seagen Inc. | 51144-003 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 16, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 1, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 19, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 26, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 1, 2013 | No problems found | Drug Quality Assurance | — |
| May 19, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: api manufacture.