Overview
- 7 public-safe observations are available for this inspection.
- 7 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.
4 Dec 2025
21 CFR 507.22(a)(1)
Equipment and Utensils - cleaned
Cited by Kenneth G Klobus, Dyanthony T Jenkins
4 Dec 2025
21 CFR 507.42(b)(2)
Adequacy of Corrective Actions Implemented
Cited by Kenneth G Klobus, Dyanthony T Jenkins
Inspected site
SMSunshine Mills, Inc.Red Bay, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 507.22(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 507.33(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 507.34(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 507.34(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 507.42(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 507.49(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 507.49(a)(2) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 7 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