Overview
- 8 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-06-03.
At a glance
Inspections
8
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 May 2022 – 3 Jun 2022 | Human Drugs | 483 | View 483 → |
| 16 Aug 2021 – 20 Aug 2021 | Human Drugs | Clean | |
| 26 Mar 2019 – 29 Mar 2019 | Human Drugs | 483 | View 483 → |
| 15 Aug 2016 – 18 Aug 2016 | Human Drugs | Clean | |
| 4 Feb 2014 – 18 Feb 2014 | Human Drugs | Clean | |
| 29 Jul 2011 | Not recorded | Clean | |
| 3 Dec 2010 | Not recorded | 483 | View 483 → |
| 14 May 2009 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
3 Jun 2022
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Yvins Dezan, Ankur C Patel, Jessica S Estriplet
3 Jun 2022
21 CFR 211.188(b)(11)
Identification of persons involved, each significant step
Cited by Yvins Dezan, Ankur C Patel, Jessica S Estriplet
3 Jun 2022
21 CFR 211.192
Extent of discrepancy, failure investigations
Cited by Yvins Dezan, Ankur C Patel, Jessica S Estriplet
3 Jun 2022
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Yvins Dezan, Ankur C Patel, Jessica S Estriplet
3 Jun 2022
21 CFR 211.46(b)
Equipment for Environmental Control
Cited by Yvins Dezan, Ankur C Patel, Jessica S Estriplet
Investigators
FDA investigators tied to this site in the record.
Susan E Polifko2 insp.
Yvins Dezan1 insp.
Ankur C Patel1 insp.
Jessica S Estriplet1 insp.
Christina K Theodorou1 insp.
Tarun D Mehta1 insp.
Simone E Pitts1 insp.
Alice S Tsao1 insp.
Craig D Zagata1 insp.
James Norman1 insp.
Thomas E Friel1 insp.
James M Mason1 insp.
Rachel C Harrington1 insp.
Tiffani D Wilson1 insp.
Denise M Digiulio1 insp.
Lisa M Bellows1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.180(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | 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(b)(11) | 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(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind ARx, LLC's 4 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