Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
17 Aug 2009
21 CFR 111.70(g)
Specifications - finished packaging, labeling
Cited by James S Cartwright, Wayne D Stowell
17 Aug 2009
21 CFR 111.210(h)(3)
Specific actions; packaged, labeled
Cited by James S Cartwright, Wayne D Stowell
17 Aug 2009
21 CFR 111.210(h)(3)(ii)(A)
Instructions; components; weight, measure
Cited by James S Cartwright, Wayne D Stowell
17 Aug 2009
21 CFR 111.260(b)
Batch record - date, time; maintenance
Cited by James S Cartwright, Wayne D Stowell
17 Aug 2009
21 CFR 111.460(a)
Hold, identify - in-process material
Cited by James S Cartwright, Wayne D Stowell
Inspected site
BOBarlean's Organic Oils LLCFerndale, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.210(h)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(h)(3)(ii)(A) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.460(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(g) | 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