Overview
- 15 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-08-01.
At a glance
Inspections
15
Form 483s
8
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Jul 2025 – 1 Aug 2025 | Human Drugs | 483 | On file |
| 5 Mar 2020 – 13 Mar 2020 | Human Drugs | 483 | View 483 → |
| 14 Jan 2020 – 21 Jan 2020 | Human Drugs | Clean | |
| 20 Sep 2018 – 28 Sep 2018 | Human Drugs | Clean | |
| 29 Jan 2018 – 2 Feb 2018 | Human Drugs | Clean | |
| 28 Nov 2017 – 4 Dec 2017 | Human Drugs | Clean | |
| 3 Apr 2017 – 24 Apr 2017 | Human Drugs | 483 | On file |
| 5 Jan 2016 – 2 Feb 2016 | Human Drugs | WL | View 483 → |
| 19 May 2014 – 3 Jun 2014 | Human Drugs | 483 | On file |
| 14 Aug 2012 | Not recorded | 483 | On file |
| 9 Aug 2011 | Not recorded | 483 | On file |
| 28 Apr 2011 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
2 Feb 2016
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Melissa T Roy, Nancy F Scheraga, Jose M Cayuela, Liatte Krueger
2 Feb 2016
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Melissa T Roy, Nancy F Scheraga, Jose M Cayuela, Liatte Krueger
2 Feb 2016
21 CFR 211.160(b)(3)
Acceptance of drug products
Cited by Melissa T Roy, Nancy F Scheraga, Jose M Cayuela, Liatte Krueger
2 Feb 2016
21 CFR 211.160(b)(3)
Acceptance of drug products
Cited by Melissa T Roy, Nancy F Scheraga, Jose M Cayuela, Liatte Krueger
Investigators
FDA investigators tied to this site in the record.
Emmanuel J Ramos2 insp.
Melissa T Roy2 insp.
Nancy F Scheraga2 insp.
Michael R Klapal2 insp.
Lata C Mathew1 insp.
Jenny Sung1 insp.
Michael Serrano1 insp.
Tonia F Bernard1 insp.
Jogy George1 insp.
Tamil Arasu1 insp.
Niketa Patel1 insp.
Jose M Cayuela1 insp.
Liatte Krueger1 insp.
Helen Verdel1 insp.
Nicholas L Paulin1 insp.
Li Li1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 314.80(c)(2) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.80(c)(1)(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.80(c)(1)(ii) | Cited across public-safe Form 483 observations | 2x |
| FDCA 505-1(e)(3) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Elite Laboratories Inc.'s 8 Form 483s
Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat