FDA Inspection
SOT LLCSOT LLC – FDA Inspection, Apr 28, 2025
Record Details
This FDA Inspection record concerns SOT LLC, with an inspection on April 28, 2025, issued by the Denver District Office, covering foods & cosmetics.
View Company Profile
ID · 56ffb9a8-d96f-4982-976c-77588b87f3d8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1268093
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling, and Economics
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 111.123(a)(8)Quality control - finished batch, distribution
- 21 CFR 111.140(b)(2)Records - date and signature; review, approval, rejection
- 21 CFR 111.205(a)Master manufacturing record - prepared
- 21 CFR 111.260Batch record - required information
- 21 CFR 111.560(a)Product complaint - qualified person review & investigate
- 21 CFR 111.70(b)Specifications - components
- 21 CFR 111.70(d)Specifications - labels, packaging
- 21 CFR 111.70(e)Specifications - finished dietary supplement
- 21 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
- 21 CFR 111.83(b)Reserve sample - container-closure system
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.