Drug factory · FDA FEI 3005890568
Cerovene, Inc.
612 Corporate Way Suite 10, Valley Cottage, NY, United States
Problems found, fixed voluntarily at FDA's last inspection, Mar 23, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
9 drug inspections on record since 2010: 5 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Amphetamine | Makes it | Dr. Reddy's Laboratories Inc. | 43598-897, 43598-898 |
| Atropine and Diphenoxylate | Makes it and tests it | Unichem Pharmaceuticals (USA), Inc. | 76385-107 |
| Famotidine | Makes it and packages it | Dr. Reddy's Laboratories Inc. | 43598-572 |
| Fluphenazine | Makes it and tests it | Dr. Reddy's Laboratories Inc. | 43598-034, 43598-035, 43598-036 +1 |
| Metyrosine | Makes it | Dr. Reddy's Laboratories Inc. | 75907-166 |
| Midodrine | Makes it and tests it | Xiromed, LLC. | 70700-157, 70700-158, 70700-159 |
| Primaquine | Makes it | Unichem Pharmaceuticals (USA), Inc. | 76385-102 |
| Pyrimethamine | Makes it and tests it | Dr. Reddy's Laboratories Inc. | 43598-672 |
| Zolmitriptan | Makes it | Jubilant Cadista Pharmaceuticals Inc. | 59746-461, 59746-462 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 23, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 1, 2023 | No problems found | Drug Quality Assurance | — |
| Nov 5, 2018 | No problems found | Drug Quality Assurance | — |
| Feb 8, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 4, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 15, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 20, 2012 | No problems found | Drug Quality Assurance | — |
| Mar 8, 2011 | No problems found | Drug Quality Assurance | — |
| Jan 4, 2010 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; manufacture; pack.