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Sisel International LLC FDA Inspection Record

FEI 3008354004 · Inspections, Form 483s, warning letters and import refusals

Sisel International LLC is an FDA-inspected facility (FEI 3008354004) located in Springville, UT, US. RegDataLab tracks 4 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Apr 11, 2025: No Action Indicated (NAI)
Inspections on record
4 (3 VAI, 1 NAI)
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
Recalls as the recalling firm
1, latest Jun 29, 2018

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 11, 2025No Action Indicated (NAI)No citations listed
Mar 10, 2022Voluntary Action Indicated (VAI)Develop FSVP (21 CFR 1.502(a))
Aug 16, 2019Voluntary Action Indicated (VAI)Written procedures - product complaint (21 CFR 111.553)
Written procedures - quality control operations (21 CFR 111.103)
Apr 3, 2017Voluntary Action Indicated (VAI)Quality control - quality, dietary supplement (21 CFR 111.65)
Documentation - specifications met; basis, quality control (21 CFR 111.75(c)(4))
Quality control operations - product complaints; investigate (21 CFR 111.135)

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Jun 29, 2018Class IIIF-1662-2018Sisel, SiselRipt, postWORKOUT, Dietary supplement, net wt 5g (0.17 oz), Internal Company…
Firm is recalling SiselRipt due to the presence of an unapproved artificial sweetener, Cyclamates.

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Sisel International LLC
Location
Springville, UT (US)
Source
inspections

FDA data resources

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