Drug factory · FDA FEI 3010209784
American Regent, Inc.
6610 New Albany Road East, New Albany, OH, United States
Problems found, fixed voluntarily at FDA's last inspection, Jan 29, 2026.
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 2015: 1 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Calcium Cation | Makes it | American Regent, Inc., Civica, Inc. | 0517-6710, 72572-052 |
| Chlorothiazide | Makes it | American Regent, Inc. | 0517-1820 |
| Estradiol | Makes it | American Regent, Inc. | 0517-0420, 0517-0440 |
| Levocarnitine | Makes it, packages it and labels it | American Regent, Inc. | 0517-1045, 0517-1075 |
| Nicardipine | Makes it | Civica, Inc. | 72572-470 |
| Olanzapine | Makes it | American Regent, Inc. | 0517-0955 |
| Phosphate Ion | Makes it, packages it and labels it | American Regent, Inc., Civica, Inc. | 0517-7305, 0517-7315, 0517-7350 +1 |
| Potassium Cation | Makes it | American Regent, Inc. | 0517-2051, 0517-2102, 0517-2505 |
| Vasopressin | Makes it, packages it and labels it | Civica, Inc. | 72572-860 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 29, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Sep 30, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Oct 28, 2016 | No problems found | Drug Quality Assurance | — |
| May 5, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 19, 2015 | 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.
Jan 29, 2026 inspection
- Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed. - 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. - Rejecting When Specifications Not Met 21 CFR 211.84(e)
Failure to reject any lot of components that did not meet the appropriate written specifications for identity, strength, quality, and purity.
Sep 30, 2022 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.
Registered with FDA for: label; manufacture; pack.