Overview
- 7 public-safe observations are available for this inspection.
- 4 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 Controls Procedures
Cited by Gerard D Difiore, Erich P Garger, Elise L Mcdevitt
Sanitary Operations - Plant Maintenance
Cited by Gerard D Difiore, Erich P Garger, Elise L Mcdevitt
Sanitary Operations - Plant Sanitation
Cited by Gerard D Difiore, Erich P Garger, Elise L Mcdevitt
Sanitation of non-food-contact surfaces - Manner and frequency
Cited by Gerard D Difiore, Erich P Garger, Elise L Mcdevitt
Manufacturing, processing, packing, holding - Controls
Cited by Gerard D Difiore, Erich P Garger, Elise L Mcdevitt
Inspected site
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.35(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 117.135(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.35(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.80(c) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 7 observations
The full inspection record, as Atlas holds it, 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