Overview
- 6 public-safe observations are available for this inspection.
- 6 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.
7 Apr 2022
21 CFR 117.130(a)(1)
Hazard Analysis - Identification of Hazard
Cited by Brenna L Macdowell, Emily J Schramm, Alysia M Salonia, Brenna L MacDowell
7 Apr 2022
21 CFR 117.145(a)
Sanitation Controls Monitoring Proced: Establish Implement
Cited by Brenna L Macdowell, Emily J Schramm, Alysia M Salonia, Brenna L MacDowell
7 Apr 2022
21 CFR 117.20(b)
Plant construction and design
Cited by Brenna L Macdowell, Emily J Schramm, Alysia M Salonia, Brenna L MacDowell
7 Apr 2022
21 CFR 117.35(a)
Sanitary operations - Plant maintenance
Cited by Brenna L Macdowell, Emily J Schramm, Alysia M Salonia, Brenna L MacDowell
7 Apr 2022
21 CFR 117.4
Training of employees and records
Cited by Brenna L Macdowell, Emily J Schramm, Alysia M Salonia, Brenna L MacDowell
Inspected site
GKGracie's Kitchens Inc.New Haven, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.130(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.145(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.20(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.35(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.4 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.80(c) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 6 observations
The full inspection record, as Atlas holds it, 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