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.
2 Jul 2026
21 CFR 111.103
Written procedures - follow; quality control operations
Cited by Ciara J Bajulai Austin, Matthew R Miranda
2 Jul 2026
21 CFR 111.210
Master manufacturing record - record requirements
Cited by Ciara J Bajulai Austin, Matthew R Miranda
2 Jul 2026
21 CFR 111.260
Batch record - required information
Cited by Ciara J Bajulai Austin, Matthew R Miranda
2 Jul 2026
21 CFR 111.320(b)
Examination, testing; scientifically valid
Cited by Ciara J Bajulai Austin, Matthew R Miranda
2 Jul 2026
21 CFR 111.560(a)
Product complaint - qualified person review & investigate
Cited by Ciara J Bajulai Austin, Matthew R Miranda
Inspected site
GHGlobal Healing Center, LLCPhoenix, United States
Inspection team
CJCiara J Bajulai Austin
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 111.210 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.320(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.560(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b) | 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(e) | 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