Overview
- 10 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-11-05.
At a glance
Inspections
10
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Oct 2018 – 5 Nov 2018 | Animal Drugs & Feeds | 483 | On file |
| 20 Mar 2017 – 31 Mar 2017 | Human Drugs | 483 | View 483 → |
| 12 Jul 2016 – 19 Jul 2016 | Human Drugs | Clean | |
| 12 Feb 2014 – 5 Mar 2014 | Human Drugs | 483 | On file |
| 15 Dec 2011 | Not recorded | 483 | View 483 → |
| 27 Apr 2011 | Not recorded | 483 | View 483 → |
| 22 Apr 2010 | Not recorded | 483 | On file |
| 28 Aug 2008 | Not recorded | 483 | On file |
| 20 Jan 2005 | Not recorded | Clean | |
| 4 Sep 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
31 Mar 2017
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Noreen Muniz, Edwin Martinez
31 Mar 2017
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Noreen Muniz, Edwin Martinez
31 Mar 2017
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Noreen Muniz, Edwin Martinez
31 Mar 2017
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Noreen Muniz, Edwin Martinez
31 Mar 2017
21 CFR 211.160(b)(4)
Calibration - at intervals, written program, remedial action
Cited by Noreen Muniz, Edwin Martinez
Investigators
FDA investigators tied to this site in the record.
Annette Melendez2 insp.
Victor S Pacheco2 insp.
Laurimer Kuilan-Torres1 insp.
Noreen Muniz1 insp.
Edwin Martinez1 insp.
Vilmary Negron Rodriguez1 insp.
Jose R Lopez1 insp.
Libia M Lugo1 insp.
Michael R Klapal1 insp.
Milva E Melendez1 insp.
Jose A Moreno1 insp.
Ramon A Hernandez1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Ex-Lax, Inc.'s 7 Form 483s
Source PDFs, verbatim observations, 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