Overview
- 6 public-safe observations are available for this inspection.
- 6 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.
4 Oct 2017
21 CFR 113.87(c)
Initial temperature of container contents
Cited by Shannon A Lowe, Dana M Lewis
4 Oct 2017
21 CFR 113.87(e)
Thermal processing - clock time agreement with time of day
Cited by Shannon A Lowe, Dana M Lewis
4 Oct 2017
21 CFR 117.35(a)
Sanitary Operations - Plant Maintenance
Cited by Shannon A Lowe, Dana M Lewis
Inspected site
FNFRITO-LAY NORTH AMERICA, INC.Arlington, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 113.40(a)(2)(iii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.87(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.87(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.89 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.35(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.35(c) | 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