Overview
- 6 public-safe observations are available for this inspection.
- 6 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.
24 Jun 2009
21 CFR 110.20(b)(4)
Drip and condensate
Cited by Marie B Buen-Bigornia, Kimberley A Hoefen, Bryan J Love
24 Jun 2009
21 CFR 110.20(b)(6)
Fans/air blowing equipment
Cited by Marie B Buen-Bigornia, Kimberley A Hoefen, Bryan J Love
24 Jun 2009
21 CFR 110.35(c)
Lack of effective pest exclusion
Cited by Marie B Buen-Bigornia, Kimberley A Hoefen, Bryan J Love
24 Jun 2009
21 CFR 110.37(e)(4)
Devices and fixtures
Cited by Marie B Buen-Bigornia, Kimberley A Hoefen, Bryan J Love
24 Jun 2009
21 CFR 110.40(a)
Precluding contaminants
Cited by Marie B Buen-Bigornia, Kimberley A Hoefen, Bryan J Love
Inspected site
NSNatures Soy, LLC dba Keystone Natural Holdings, LLC Bolder DivisionBoulder, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.20(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(1) | 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