Overview
- 5 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
21 Sep 2019
21 CFR 113.40(g)(1)(i)(B)
Aseptic processing: recorder, permanent record
Cited by Young Kim, Laura D Cain
Inspected site
GFGehl Foods SoutheastWalterboro, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 108.35(c)(3)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 108.35(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.40(g)(1)(i)(B) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.40(g)(1)(i)(B)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.60(c) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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