Elite Laboratories Inc.
FDA Regulatory Profile
Elite Laboratories Inc. has 1 FDA recall, 10 inspections, 0 510(k) clearances and 1 compliance action on record.
- Latest recall
- D-0107-2018 · Class III · Nov 13, 2017
- Latest inspection
- Aug 1, 2025 · VAI
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 1 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 10 | Nov 10, 2026 | Newest record Nov 5, 2026 | Current |
|---|
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0107-2018 | Class III | Isradapine Capsules USP 2.5 mg, 100-count bottles, Rx only, Manufactured by: Elite Laboratories… | Nov 13, 2017 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Aug 1, 2025 | Northvale, NJ | Drugs | Voluntary Action Indicated (VAI) | 3002644678 |
| Mar 13, 2020 | Northvale, NJ | Drugs | Voluntary Action Indicated (VAI) | 3002644678 |
| Jan 21, 2020 | Northvale, NJ | Drugs | No Action Indicated (NAI) | 3002644678 |
| Feb 2, 2018 | Northvale, NJ | Drugs | No Action Indicated (NAI) | 3002644678 |
| Dec 4, 2017 | Northvale, NJ | Drugs | No Action Indicated (NAI) | 3002644678 |
| Apr 24, 2017 | Northvale, NJ | Drugs | Voluntary Action Indicated (VAI) | 3002644678 |
| Feb 2, 2016 | Northvale, NJ | Drugs | Official Action Indicated (OAI) | 3002644678 |
| Jun 3, 2014 | Northvale, NJ | Drugs | Voluntary Action Indicated (VAI) | 3002644678 |
| Aug 14, 2012 | Northvale, NJ | Drugs | Voluntary Action Indicated (VAI) | 3002644678 |
| Apr 28, 2011 | Northvale, NJ | Drugs | Voluntary Action Indicated (VAI) | 3002644678 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3002644678 | Northvale, NJ | 10 | Aug 1, 2025 |