Overview
- 6 public-safe observations are available for this inspection.
- 6 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.
13 Feb 2026
21 CFR 111.113(a)(3)
Quality control - adulteration; material review, disposition
Cited by Khunnathee Stoner, Jessica A Isaac
13 Feb 2026
21 CFR 111.205(b)(1)
Master manufacturing record - specifications, quality; packaging, labeling
Cited by Khunnathee Stoner, Jessica A Isaac
13 Feb 2026
21 CFR 111.70(e)
Specifications - finished dietary supplement
Cited by Khunnathee Stoner, Jessica A Isaac
13 Feb 2026
21 CFR 111.75(a)(1)(i)
Component - verify identity, dietary ingredient
Cited by Khunnathee Stoner, Jessica A Isaac
Inspected site
IGILS GUMMIES, LLCMckinney, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.113(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(b)(1) | 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(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(2)(ii)(A) | 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