Overview
- 9 public-safe observations are available for this inspection.
- 6 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.
10 Jun 2010
21 CFR 110.10(b)(3)
Not washed/sanitized when appropriate
Cited by Cindy W Lewis, Lija V Fellows, Mabel M Lee
10 Jun 2010
21 CFR 110.35(a)
Cleaning and sanitizing operations
Cited by Cindy W Lewis, Lija V Fellows, Mabel M Lee
10 Jun 2010
21 CFR 110.37(a)
Suitable temp. and pressure
Cited by Cindy W Lewis, Lija V Fellows, Mabel M Lee
Inspected site
FEFresh Express IncorporatedSalinas, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.80 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 110.35(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.10(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.40(a) | 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