Overview
- 7 public-safe observations are available for this inspection.
- 7 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.
8 Apr 2026
21 CFR 111.70(e)
Specifications - finished dietary supplement
Cited by Courtney R Ingalsbe, Beatrix D Hippe, Elizabeth R Bloom
8 Apr 2026
21 CFR 114.83
Scheduled process establishment
Cited by Courtney R Ingalsbe, Beatrix D Hippe, Elizabeth R Bloom
8 Apr 2026
21 CFR 117.130(a)(1)
Hazard analysis - Identification of hazard
Cited by Courtney R Ingalsbe, Beatrix D Hippe, Elizabeth R Bloom
8 Apr 2026
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Courtney R Ingalsbe, Beatrix D Hippe, Elizabeth R Bloom
8 Apr 2026
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Courtney R Ingalsbe, Beatrix D Hippe, Elizabeth R Bloom
Inspected site
PUPadagis US LLCMinneapolis, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 114.83 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.130(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(b) | 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