Overview
- 4 public-safe observations are available for this inspection.
- 4 structured CFR citations are represented.
- 10 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
Buildings/good repair
Cited by Patrick E Gainer, Brian P Emanuel, Marcia A Worley, Margaret Torres-Vazquez, Andrew A Leboeuf, James W Plucinski, Lauren A Crivellone, Jeanne J Chiu, Tara C Alcazar, Susan W Ciani
Lack of effective pest exclusion
Cited by Patrick E Gainer, Brian P Emanuel, Marcia A Worley, Margaret Torres-Vazquez, Andrew A Leboeuf, James W Plucinski, Lauren A Crivellone, Jeanne J Chiu, Tara C Alcazar, Susan W Ciani
Non food-contact equipment in processing area
Cited by Patrick E Gainer, Brian P Emanuel, Marcia A Worley, Margaret Torres-Vazquez, Andrew A Leboeuf, James W Plucinski, Lauren A Crivellone, Jeanne J Chiu, Tara C Alcazar, Susan W Ciani
Holding, conveying, mfg systems - design & construction
Cited by Patrick E Gainer, Brian P Emanuel, Marcia A Worley, Margaret Torres-Vazquez, Andrew A Leboeuf, James W Plucinski, Lauren A Crivellone, Jeanne J Chiu, Tara C Alcazar, Susan W Ciani
Inspected site
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.35(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.40(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.40(d) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 4 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