Overview
- 3 public-safe observations are available for this inspection.
- 3 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.
3 Feb 2017
21 CFR 117.80(c)
Manufacturing, Processing, Packing, Holding - Controls
Cited by Janet B Gray, Adam J Williams, Amanda L Evanco
3 Feb 2017
21 CFR 117.35(a)
Sanitary Operations - Plant Maintenance
Cited by Janet B Gray, Adam J Williams, Amanda L Evanco
3 Feb 2017
21 CFR 117.40
Equipment and Utensils - Design and Maintenance
Cited by Janet B Gray, Adam J Williams, Amanda L Evanco
Inspected site
FFFresh Frozen FoodsJefferson, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.35(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.80(c) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 3 observations
The source PDF and 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