Drug factory · FDA FEI 1525864
Adare Pharmaceuticals, Inc.
845 Center Dr., Vandalia, OH, United States
Problems found, fixed voluntarily at FDA's last inspection, Feb 25, 2025.
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: 6 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Cyclobenzaprine | Makes it | Amneal Pharmaceuticals | 0115-1436, 0115-1437 |
| Fenofibric Acid | Makes it, tests it and packages it | Rhodes Pharmaceuticals L.P. | 42858-454, 42858-660 |
| Potassium Cation | Makes it | Adare Pharmaceuticals Inc, Caraco Pharmaceutical Laboratories, Ltd. | 59917-102, 59917-103, 63304-076 +3 |
| Propranolol | Makes it | Breckenridge Pharmaceutical, Inc. | 51991-817, 51991-818, 51991-819 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 25, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Jan 25, 2019 | No problems found | Drug Quality Assurance | — |
| Jul 11, 2018 | No problems found | Bioresearch Monitoring | — |
| May 19, 2017 | No problems found | Drug Quality Assurance | — |
| Nov 16, 2012 | No problems found | Drug Quality Assurance | — |
| Dec 21, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 17, 2011 | No problems found | Drug Quality Assurance | — |
| Nov 20, 2009 | No problems found | 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.
Feb 25, 2025 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.
Registered with FDA for: analysis; api manufacture; manufacture; pack.