Overview
- 27 FDA inspections are on record.
- 11 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-07-24.
At a glance
Inspections
27
Form 483s
11
EIRs
2
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Jul 2023 – 24 Jul 2023 | Human Drugs | Clean | |
| 31 Jan 2018 – 5 Feb 2018 | Human Drugs | Clean | |
| 15 May 2017 – 19 May 2017 | Human Drugs | 483 | On file |
| 23 Jan 2017 – 15 Feb 2017 | Human Drugs | 483 | On file |
| 8 Nov 2016 – 5 Dec 2016 | Human Drugs | 483 | On file |
| 29 Jul 2015 – 27 Aug 2015 | Human Drugs | 483 | On file |
| 3 Nov 2014 – 2 Dec 2014 | Human Drugs | Clean | |
| 16 Jul 2013 – 25 Jul 2013 | Human Drugs | Clean | |
| 24 Jan 2013 – 15 Feb 2013 | Human Drugs | 483 | On file |
| 12 Feb 2013 | Not recorded | Clean | |
| 13 Jan 2012 | Not recorded | 483 | On file |
| 26 Apr 2011 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Feb 2017
21 CFR 211.165(a)
Testing and release for distribution
Cited by Yvesna C Blaise, Sachinkumar V Patel, Guerlain Ulysse
15 Feb 2017
21 CFR 211.165(a)
Testing and release for distribution
Cited by Yvesna C Blaise, Sachinkumar V Patel, Guerlain Ulysse
15 Feb 2013
21 CFR 314.81(b)(1)(ii)
Failure to meet specifications
Cited by Douglas C Kovacs, Stephen J Mottola
26 Apr 2011
21 CFR 314.80(b)
Failure to develop written procedures
Cited by Michael Serrano, Liatte Krueger, Stephen J Mottola, Erin D Mccaffery
26 Apr 2011
21 CFR 314.80(b)
Failure to review ADE information
Cited by Michael Serrano, Liatte Krueger, Stephen J Mottola, Erin D Mccaffery
Investigators
FDA investigators tied to this site in the record.
Erin D Mccaffery4 insp.
Guerlain Ulysse3 insp.
Douglas C Kovacs3 insp.
Stephen J Mottola3 insp.
Yvesna C Blaise2 insp.
Barbara J Wilimczyk-Macri2 insp.
Liatte Krueger2 insp.
Michael R Klapal2 insp.
Ankur C Patel1 insp.
Melissa T Roy1 insp.
Nancy F Scheraga1 insp.
Xiaohan Cai1 insp.
Sachinkumar V Patel1 insp.
Emmanuel J Ramos1 insp.
Zakaria I Ganiyu1 insp.
Niketa Patel1 insp.
Jose M Cayuela1 insp.
Helen Verdel1 insp.
Michael Serrano1 insp.
Robert D Tollefsen1 insp.
Li Li1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Actavis Elizabeth LLC's 11 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