Drug factory · FDA FEI 3001905562
API, Inc.
10 Industrial Road, Fairfield, NJ, United States
Problems found, fixed voluntarily at FDA's last inspection, Aug 8, 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 2011: 3 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Dordaviprone | Makes the active ingredient | Jazz Pharmaceuticals, Inc. | 68727-250 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 8, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 26, 2017 | No problems found | Drug Quality Assurance | — |
| Mar 13, 2014 | No problems found | Drug Quality Assurance | — |
| Apr 6, 2012 | No problems found | Drug Quality Assurance | — |
| Jul 15, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: api manufacture.