Overview
- 8 public-safe observations are available for this inspection.
- 8 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.
9 Apr 2026
21 CFR 111.103
Written procedures - establish; quality control operations
Cited by Sonia R Peterson, Tony J Wu
9 Apr 2026
21 CFR 111.153
Written procedures - establish; components
Cited by Sonia R Peterson, Tony J Wu
9 Apr 2026
21 CFR 111.453
Written procedures - establish; holding and distribution
Cited by Sonia R Peterson, Tony J Wu
9 Apr 2026
21 CFR 111.503
Written procedures - establish; returned dietary supplements
Cited by Sonia R Peterson, Tony J Wu
9 Apr 2026
21 CFR 111.553
Written procedures - establish; product complaint
Cited by Sonia R Peterson, Tony J Wu
Inspected site
AGAmerica Great HealthAlhambra, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.153 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.453 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.503 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.553 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.83(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 8 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