Overview
- 12 public-safe observations are available for this inspection.
- 6 structured CFR citations are represented.
- 5 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
27 Sep 2021
21 CFR 117.135(a)(1)
Preventive Controls - Identify
Cited by Alexandra B Pitkin, Michael S Call, Phillip J Sample, Breena L D'Ambrogi, Jorge L Bertran
27 Sep 2021
21 CFR 117.135(a)(1)
Preventive Controls - Identify
Cited by Alexandra B Pitkin, Michael S Call, Phillip J Sample, Breena L D'Ambrogi, Jorge L Bertran
27 Sep 2021
21 CFR 117.150(a)(1)
Process Controls Corrective Action Proced: Estab Implement
Cited by Alexandra B Pitkin, Michael S Call, Phillip J Sample, Breena L D'Ambrogi, Jorge L Bertran
27 Sep 2021
21 CFR 117.150(a)(1)
Process Controls Corrective Action Proced: Estab Implement
Cited by Alexandra B Pitkin, Michael S Call, Phillip J Sample, Breena L D'Ambrogi, Jorge L Bertran
27 Sep 2021
21 CFR 117.165(b)
Sanitation Controls Verif Procedures: Establish Implement
Cited by Alexandra B Pitkin, Michael S Call, Phillip J Sample, Breena L D'Ambrogi, Jorge L Bertran
Inspected site
GEGrimmway Enterprises Inc.Arvin, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.135(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 117.150(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 117.165(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 120.11(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 120.7(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 120.8(b)(3) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 12 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