Drug factory · FDA FEI 3003433784
American Regent, Inc.
960 Crupper Avenue, Columbus, OH, United States
Problems found, fixed voluntarily at FDA's last inspection, Mar 5, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
8 drug inspections on record since 2009: 4 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Betamethasone | Tests it | American Regent, Inc. | 0517-0720, 0517-0791, 0517-0799 |
| Chlorothiazide | Tests it | American Regent, Inc. | 0517-1820 |
| Estradiol | Tests it | American Regent, Inc. | 0517-0420, 0517-0440 |
| Ferric Cation | Tests it | American Regent, Inc., Fresenius Medical Care Holdings, Inc., Sandoz Inc. | 0517-0602, 0517-0620, 0517-0650 +6 |
| Fomepizole | Tests it | American Regent, Inc. | 0517-0710 |
| Nicardipine | Tests it | American Regent, Inc., Civica, Inc. | 0517-0735, 72572-470 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 5, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Nov 19, 2021 | No problems found | Drug Quality Assurance | — |
| Nov 15, 2017 | No problems found | Drug Quality Assurance | — |
| Mar 9, 2017 | No problems found | Drug Quality Assurance | — |
| Aug 8, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 11, 2013 | No problems found | Drug Quality Assurance | — |
| Feb 7, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 26, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Mar 5, 2026 inspection
- Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Registered with FDA for: analysis.