Overview
- 16 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-08-12.
At a glance
Inspections
16
Form 483s
9
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Aug 2021 – 12 Aug 2021 | Human Drugs | 483 | On file |
| 29 Jul 2019 – 31 Jul 2019 | Human Drugs | 483 | View 483 → |
| 3 May 2019 – 31 May 2019 | Human Drugs | 483 | On file |
| 16 Jul 2018 – 18 Jul 2018 | Human Drugs | 483 | On file |
| 9 Jan 2018 – 11 Jan 2018 | Human Drugs | Clean | |
| 23 Jan 2017 – 3 Feb 2017 | Human Drugs | 483 | On file |
| 22 Apr 2015 – 7 May 2015 | Human Drugs | 483 | View 483 → |
| 28 Oct 2013 – 8 Nov 2013 | Human Drugs | Clean | |
| 6 Dec 2012 | Not recorded | 483 | On file |
| 20 Aug 2010 | Not recorded | Clean | |
| 2 Feb 2009 | Not recorded | 483 | On file |
| 26 Mar 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
31 Jul 2019
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Bei Y He, Wayne D Mcgrath
7 May 2015
21 CFR 211.166(a)
Written program not followed
Cited by Robert J Ham, Michele Perry-Williams, Michele Perry Williams
Investigators
FDA investigators tied to this site in the record.
Michele Perry-Williams4 insp.
Robert J Ham2 insp.
Wayne D Mcgrath2 insp.
Michele Perry Williams2 insp.
Alan M Barker1 insp.
Bei Y He1 insp.
Shirshendu K Deb1 insp.
Andrew J Idzior1 insp.
Yaodong Huang1 insp.
Karen M Montgomery1 insp.
Kellia N Hicks1 insp.
Dawn C Olenjack1 insp.
Shafiq Ahadi1 insp.
Tara L Breckenridge1 insp.
Thuy T Nguyen1 insp.
Eric M Mueller1 insp.
Matthew R Sleeter1 insp.
Sherry G Bous1 insp.
Joseph R Lambert1 insp.
Gwyn G Dickinson1 insp.
Erika V Butler1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.204 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.80(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Nesher Pharmaceuticals (USA) LLC'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