Overview
- 9 public-safe observations are available for this inspection.
- 9 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
12 Jul 2019
21 CFR 117.130(a)(1)
Hazard Analysis - Identification of Hazard
Cited by Sundy V Sedwick, Dena L Jacobs, Sondra R Davis
12 Jul 2019
21 CFR 117.135(a)(1)
Preventive Controls - Identify
Cited by Sundy V Sedwick, Dena L Jacobs, Sondra R Davis
12 Jul 2019
21 CFR 117.150(a)(1)
Process Controls Corrective Action Proced: Estab Implement
Cited by Sundy V Sedwick, Dena L Jacobs, Sondra R Davis
12 Jul 2019
21 CFR 117.150(b)(2)
Corrective Action for Unanticipated Food Safety Problems
Cited by Sundy V Sedwick, Dena L Jacobs, Sondra R Davis
Inspected site
PGPure Ground Ingredients, Inc.Minden, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.10 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.130(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.135(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.150(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.150(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.35(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.405(a)(1) | 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 9 observations
Every observation in full, 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