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.
30 Dec 2008
21 CFR 110.10(b)(3)
Not washed/sanitized when appropriate
Cited by Brian P Emanuel, Leslie D Hintz, Paola S Barnett, Jessica L Burley
30 Dec 2008
21 CFR 110.20(b)(4)
Floors, walls and ceilings
Cited by Brian P Emanuel, Leslie D Hintz, Paola S Barnett, Jessica L Burley
30 Dec 2008
21 CFR 110.20(b)(6)
Adequate ventilation
Cited by Brian P Emanuel, Leslie D Hintz, Paola S Barnett, Jessica L Burley
30 Dec 2008
21 CFR 110.20(b)(7)
Screening
Cited by Brian P Emanuel, Leslie D Hintz, Paola S Barnett, Jessica L Burley
30 Dec 2008
21 CFR 110.37(b)(3)
As source of contamination
Cited by Brian P Emanuel, Leslie D Hintz, Paola S Barnett, Jessica L Burley
Inspected site
FEFresh Express IncorporatedStreamwood, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.10(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 6 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