Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
16 Jan 2018
21 CFR 117.130(a)(1)
Hazard Analysis - Identification of Hazard
Cited by John N Woodall, Kathryn A Guardiola, Jacob A Clark, Kathryn A Cutajar
16 Jan 2018
21 CFR 117.35(b)(1)
Cleaning and sanitizing substances- safe and adequate
Cited by John N Woodall, Kathryn A Guardiola, Jacob A Clark, Kathryn A Cutajar
16 Jan 2018
21 CFR 117.35(d)
Sanitation of food contact surfaces - frequency
Cited by John N Woodall, Kathryn A Guardiola, Jacob A Clark, Kathryn A Cutajar
16 Jan 2018
21 CFR 117.405(a)(1)
Supply-Chain Program Establish and Implement
Cited by John N Woodall, Kathryn A Guardiola, Jacob A Clark, Kathryn A Cutajar
16 Jan 2018
21 CFR 117.40(f)
Instruments and Controls
Cited by John N Woodall, Kathryn A Guardiola, Jacob A Clark, Kathryn A Cutajar
Inspected site
FPFresh Pak, Inc.Detroit, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.130(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.35(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.35(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.40(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.405(a)(1) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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