Overview
- 11 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-02-10.
At a glance
Inspections
11
Form 483s
8
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Jan 2022 – 10 Feb 2022 | Human Drugs | 483 | View 483 → |
| 31 Aug 2020 – 14 Jun 2021 | Human Drugs | 483 | View 483 → |
| 23 Jul 2018 – 20 Aug 2018 | Human Drugs | WL | View 483 → |
| 13 Jul 2016 – 4 Aug 2016 | Human Drugs | 483 | View 483 → |
| 7 Jul 2015 – 16 Jul 2015 | Human Drugs | 483 | View 483 → |
| 16 Sep 2014 – 30 Oct 2014 | Human Drugs | 483 | View 483 → |
| 20 Sep 2013 – 30 Oct 2013 | Human Drugs | 483 | View 483 → |
| 27 Sep 2011 | Not recorded | 483 | View 483 → |
| 3 Sep 2009 | Not recorded | Clean | |
| 8 Feb 2007 | Not recorded | Clean | |
| 16 Mar 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Feb 2022
21 CFR 211.166(a)
Lack of written stability program
Cited by Sean R Marcsisin, Leanna M Slarsky
10 Feb 2022
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Sean R Marcsisin, Leanna M Slarsky
10 Feb 2022
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Sean R Marcsisin, Leanna M Slarsky
Investigators
FDA investigators tied to this site in the record.
Sean R Marcsisin3 insp.
Justine M Corson3 insp.
Leanna M Slarsky2 insp.
Jonathan G Matrisciano2 insp.
Daniel L Zheng1 insp.
Lori M Newman1 insp.
Margaret M Sands1 insp.
Uttaniti Limchumroon1 insp.
William J Leonard1 insp.
Cassandra L Abellard1 insp.
Kim L Thomas Cruse1 insp.
Yvonne Y Wu1 insp.
Mary-Jeanet Mcgarry1 insp.
Amy C Jordan1 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 211.22(d) | Cited across public-safe Form 483 observations | 8x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.84(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.122(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.134(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Pharmasol Corporation's 8 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