Overview
- 4 public-safe observations are available for this inspection.
- 3 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
27 Mar 2019
21 CFR 117.165(b)
Sanitation Controls Verif Procedures: Establish Implement
Cited by Michael S Hudson
27 Mar 2019
21 CFR 117.150(a)(1)
Other Controls Corrective Action Proced: Establish Implement
Cited by Michael S Hudson
27 Mar 2019
21 CFR 117.165(b)
Allergen Controls Verif Procedures: Establish Implement
Cited by Michael S Hudson
27 Mar 2019
21 CFR 117.405(a)(1)
Supply-Chain Program Establish and Implement
Cited by Michael S Hudson
Inspected site
GVGreen Valley Group, LLCEugene, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.165(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 117.150(a)(1) | 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 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