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SOT LLC FDA Inspection Record

FEI 3016721524 · Inspections, Form 483s, warning letters and import refusals

SOT LLC is an FDA-inspected facility (FEI 3016721524) located in Commerce City, CO, US. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
Apr 28, 2025: Voluntary Action Indicated (VAI)
Inspections on record
1 (1 VAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Apr 28, 2025Voluntary Action Indicated (VAI)Specifications - labels, packaging (21 CFR 111.70(d))
Component - qualify supplier (21 CFR 111.75(a)(2)(ii)(A))
Quality control - finished batch, distribution (21 CFR 111.123(a)(8))
Specifications - components (21 CFR 111.70(b))
and 6 more

Facility details

Company
SOT LLC
Location
Commerce City, CO (US)
Source
inspections

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.