Overview
- 4 public-safe observations are available for this inspection.
- 4 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.
5 May 2016
21 CFR 111.403
Written procedures - labeling operations
Cited by Nicole Vaught, Nada F Agabani
5 May 2016
21 CFR 111.415(d)
Packaging, labeling - physical separation
Cited by Nicole Vaught, Nada F Agabani
5 May 2016
21 CFR 111.560(a)(2)
Product complaint - quality control investigate
Cited by Nicole Vaught, Nada F Agabani
5 May 2016
21 CFR 111.570(b)(2)(i)
Record - person document; time of performance
Cited by Nicole Vaught, Nada F Agabani
Inspected site
NONatural Organics, Inc.Melville, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.403 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.415(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.560(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.570(b)(2)(i) | 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