Overview
- 18 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-05-20.
At a glance
Inspections
18
Form 483s
8
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 Apr 2021 – 20 May 2021 | Human Drugs | 483 | View 483 → |
| 8 Aug 2019 – 31 Oct 2019 | Human Drugs | 483 | On file |
| 4 Jan 2016 – 5 Feb 2016 | Human Drugs | WL | View 483 → |
| 22 Jan 2014 – 26 Mar 2014 | Human Drugs | 483 | View 483 → |
| 12 Apr 2011 | Not recorded | 483 | View 483 → |
| 24 Mar 2010 | Not recorded | 483 | View 483 → |
| 17 Sep 2009 | Not recorded | Clean | |
| 17 Mar 2009 | Not recorded | 483 | View 483 → |
| 30 Sep 2008 | Not recorded | 483 | On file |
| 9 Jan 2008 | Not recorded | Clean | |
| 28 Sep 2007 | Not recorded | Clean | |
| 17 Aug 2006 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
20 May 2021
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Justin A Boyd, Sarah E Rhoades, Arsen Karapetyan, Nibin Varghese
20 May 2021
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Justin A Boyd, Sarah E Rhoades, Arsen Karapetyan, Nibin Varghese
20 May 2021
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Justin A Boyd, Sarah E Rhoades, Arsen Karapetyan, Nibin Varghese
20 May 2021
21 CFR 211.165(e)
Test methods
Cited by Justin A Boyd, Sarah E Rhoades, Arsen Karapetyan, Nibin Varghese
20 May 2021
21 CFR 211.166(a)
Written program not followed
Cited by Justin A Boyd, Sarah E Rhoades, Arsen Karapetyan, Nibin Varghese
Investigators
FDA investigators tied to this site in the record.
Brian D Nicholson2 insp.
Lequita M Mayhew2 insp.
Russell K Riley2 insp.
Justin A Boyd1 insp.
Sarah E Rhoades1 insp.
Arsen Karapetyan1 insp.
Nibin Varghese1 insp.
Linda F Murphy1 insp.
Michele L Glendenning1 insp.
Sandra A Boyd1 insp.
Aditi Thakur1 insp.
Robert D Tollefsen1 insp.
Christopher D Leach1 insp.
Amanda S Zorn1 insp.
Jason F Chancey1 insp.
Carrie-Ann Plucinski1 insp.
Phung T Nguyen1 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 211.68(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.110(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.180(e) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.84(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.89 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(1) | 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 Morton Grove Pharmaceuticals, Inc.'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