Overview
- 7 public-safe observations are available for this inspection.
- 7 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.
Sanitation monitoring documentation
Cited by Tracy M Portelli, Robert E Moncayo, Melinee C Minhas
HACCP plan implementation
Cited by Tracy M Portelli, Robert E Moncayo, Melinee C Minhas
Food safety hazards
Cited by Tracy M Portelli, Robert E Moncayo, Melinee C Minhas
Critical limits
Cited by Tracy M Portelli, Robert E Moncayo, Melinee C Minhas
Verification procedures - adequacy
Cited by Tracy M Portelli, Robert E Moncayo, Melinee C Minhas
Inspected site
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 123.11(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(c)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.7(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.9(a) | Cited across public-safe Form 483 observations | 1x |
Source document
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 7 observations
The source PDF, 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