Overview
- 12 public-safe observations are available for this inspection.
- 11 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
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
Inspected site
MGMorton Grove Pharmaceuticals, Inc.Morton Grove, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | 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 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
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Form 483 source document
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Full 483 report
Get the verbatim text of all 12 observations
The source PDF, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere