Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
1 Jul 2022
21 CFR 111.20(b)
Physical plant - space; equipment, materials
Cited by Gary C Pecic, Erica R Woody, Meaghan M Rabideau
1 Jul 2022
21 CFR 111.210(h)(2)
Master manufacturing record - sampling, tests, examinations
Cited by Gary C Pecic, Erica R Woody, Meaghan M Rabideau
1 Jul 2022
21 CFR 111.260(g)
Batch record - results; monitoring
Cited by Gary C Pecic, Erica R Woody, Meaghan M Rabideau
1 Jul 2022
21 CFR 111.65
Quality control - quality, dietary supplement
Cited by Gary C Pecic, Erica R Woody, Meaghan M Rabideau
Inspected site
ANArizona Nutritional Supplements LLCChandler, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.10(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(h)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.65 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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