Overview
- 11 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-01-18.
At a glance
Inspections
11
Form 483s
9
EIRs
4
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Jan 2019 – 18 Jan 2019 | Human Drugs | Clean | |
| 15 Aug 2017 – 23 Aug 2017 | Human Drugs | 483 | View 483 → |
| 4 Apr 2016 – 4 May 2016 | Human Drugs | 483 | View 483 → |
| 6 Apr 2015 – 8 May 2015 | Human Drugs | 483 | View 483 → |
| 16 Jun 2014 – 31 Jul 2014 | Human Drugs | 483 | On file |
| 8 Jan 2013 – 28 Feb 2013 | Human Drugs | 483 | View 483 → |
| 28 Mar 2012 | Not recorded | 483 | View 483 → |
| 21 Jan 2011 | Not recorded | 483 | View 483 → |
| 22 Apr 2010 | Not recorded | 483 | On file |
| 7 Aug 2009 | Not recorded | 483 | On file |
| 8 Feb 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
23 Aug 2017
21 CFR 314.80(c)(1)(iii)
Non-applicant reports to applicant
Cited by James A Lane, Rumany C Penn
Investigators
FDA investigators tied to this site in the record.
Lucila B Nwatu3 insp.
Stephanie A Slater3 insp.
William V Millar3 insp.
Lance M De Souza2 insp.
Peter E Baker2 insp.
James A Lane1 insp.
Rumany C Penn1 insp.
Elizabeth Juarez1 insp.
Anh Lac1 insp.
Ashar P Parikh1 insp.
Rebecca Rodriguez1 insp.
Uduak M Inokon1 insp.
Eric L Dong1 insp.
Walden H Lee1 insp.
Daniel J Roberts1 insp.
Kim L Thomas Cruse1 insp.
Kevin P Foley1 insp.
Sharon K Thoma1 insp.
Rochelle B Young1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 10x |
| 21 CFR 314.80(c)(1)(iii) | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.65(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(2)(iv)(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Impax Laboratories, Inc.'s 9 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