Drug factory · FDA FEI 1525964
ISP Chemicals LLC
1979 Atlas Street, Columbus, OH, United States
Problems found, fixed voluntarily at FDA's last inspection, Jan 29, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2009: 4 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Mitotane | Makes the active ingredient | Esteve Pharmaceuticals, S.a., HRA Pharma Rare Diseases | 68118-080, 76336-080 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 29, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 20, 2018 | No problems found | Drug Quality Assurance | — |
| Feb 13, 2017 | No problems found | Drug Quality Assurance | — |
| Dec 19, 2012 | No problems found | Drug Quality Assurance | — |
| Aug 5, 2009 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: api manufacture.