Overview
- 6 public-safe observations are available for this inspection.
- 6 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
17 Sep 2021
21 CFR 117.145(a)
Sanitation Controls Monitoring Proced: Establish Implement
Cited by Victoria L Morgan, Michael D Kawalek, Elaine S Chow, Jorge L Bertran
17 Sep 2021
21 CFR 117.165(b)
Other Controls Verification Procedures: Establish Implement
Cited by Victoria L Morgan, Michael D Kawalek, Elaine S Chow, Jorge L Bertran
17 Sep 2021
21 CFR 117.35(a)
Sanitary operations - Plant maintenance
Cited by Victoria L Morgan, Michael D Kawalek, Elaine S Chow, Jorge L Bertran
17 Sep 2021
21 CFR 117.405(a)(1)
Supply-Chain Program Establish and Implement
Cited by Victoria L Morgan, Michael D Kawalek, Elaine S Chow, Jorge L Bertran
17 Sep 2021
21 CFR 117.405(c)
Hazard Controlled by Entity other than Supplier
Cited by Victoria L Morgan, Michael D Kawalek, Elaine S Chow, Jorge L Bertran
Inspected site
HQHigh Quality Organics, Inc.Reno, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.145(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.35(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.405(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.405(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.415(a)(2) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 6 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