Drug factory · FDA FEI 3002644678
Elite Laboratories, Inc.
165\144\135 Ludlow Avenue, Northvale, NJ, United States
Problems found, fixed voluntarily at FDA's last inspection, Aug 1, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
12 drug inspections on record since 2011: 3 with no problems, 8 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 1, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 13, 2020 | Problems found, fixed voluntarily | Bioresearch Monitoring | 2 |
| Mar 13, 2020 | Problems found, fixed voluntarily | Bioresearch Monitoring | 2 |
| Jan 21, 2020 | No problems found | Drug Quality Assurance | — |
| Feb 2, 2018 | No problems found | Drug Quality Assurance | — |
| Dec 4, 2017 | No problems found | Drug Quality Assurance | — |
| Apr 24, 2017 | Problems found, fixed voluntarily | Postmarket Surv. and Epidemiology | — |
| Apr 24, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 2, 2016 | Serious problems, FDA action | Bioresearch Monitoring | — |
| Jun 3, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 14, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 28, 2011 | 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.
Mar 13, 2020 inspection
- Failure to comply with REMS Communication Plan FDCA 505-1(e)(3)
You did not use the Communication Plan distribution methods described in the REMS, as required by your approved REMS Communication Plan. - Failure to comply with REMS Communication Plan FDCA 505-1(e)(3)
You did not use the Communication Plan distribution methods described in the REMS, as required by your approved REMS Communication Plan.
Registered with FDA for: label; manufacture.