Drug factory · FDA FEI 3013326213
Innogenix, LLC.
8200 New Horizons Blvd, Amityville, NY, United States
No problems found at FDA's last inspection, Mar 13, 2025.
No Action Indicated: inspectors found no objectionable conditions.
3 drug inspections on record since 2018: 2 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Baclofen | Makes it, tests it and packages it | Camber Pharmaceuticals Inc., XLCare Pharmaceuticals, Inc. | 31722-138, 31722-998, 31722-999 +3 |
| Haloperidol | Makes it, tests it, packages it and labels it | Amici Pharmaceuticals, LLC., Innogenix, Inc. | 69292-580, 69292-582, 69292-584 +9 |
| Metolazone | Makes it | Amici Pharma Inc. | 69292-562, 69292-564, 69292-566 |
| Metronidazole | Makes it | Amici Pharma Inc. | 69292-207, 69292-208 |
| Propranolol | Makes it | Amici Pharmaceuticals, LLC. | 69292-530, 69292-532, 69292-534 +2 |
| Ramelteon | Makes it and packages it | Kanchan Healthcare Inc | 85742-023 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 13, 2025 | No problems found | Bioresearch Monitoring | — |
| Nov 15, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 14, 2018 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack.