Drug factory · FDA FEI 3005761472
American Regent, Inc.
4150 Lyman Drive, Hilliard, OH, United States
Problems found, fixed voluntarily at FDA's last inspection, Jun 18, 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: 2 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Betamethasone | Makes it | American Regent, Inc. | 0517-0720, 0517-0791, 0517-0799 |
| Epinephrine | Makes it | American Regent, Inc. | 0517-3030 |
| Ferric Cation | Makes it | American Regent, Inc., Fresenius Medical Care Holdings, Inc., Sandoz Inc. | 0517-0602, 0517-0620, 0517-0650 +6 |
| Fomepizole | Makes it | American Regent, Inc. | 0517-0710 |
| Hydroxyprogesterone | Makes it | Amneal Pharmaceuticals | 69238-1797 |
| Vasopressin | Makes it | American Regent, Inc. | 0517-1020, 0517-1030 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 18, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Jul 20, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 8, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Aug 18, 2017 | No problems found | Drug Quality Assurance | — |
| Dec 7, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Apr 4, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 30, 2011 | No problems found | Drug Quality Assurance | — |
| Jan 23, 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.
Jun 18, 2026 inspection
- Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Mar 8, 2019 inspection
- SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions. - Failure to meet specifications 21 CFR 314.81(b)(1)(ii)
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning a failure of one or more distributed batches of a drug to meet the specifications established for it in the application.
Dec 7, 2016 inspection
- Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed. - Buildings not maintained in good state of repair 21 CFR 211.58
Buildings used in the manufacturing, processing and holding of a drug product are not maintained in a good state of repair. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Registered with FDA for: manufacture.