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Far East Summit LLC FDA Inspection Record

FEI 3008018326 · Inspections, Form 483s, warning letters and import refusals

Far East Summit LLC is an FDA-inspected facility (FEI 3008018326) located in Dexter, OR, US. RegDataLab tracks 6 FDA inspections and 1 compliance action at this facility.

What FDA found at this site

Latest inspection
Apr 18, 2025: Voluntary Action Indicated (VAI)
Inspections on record
6 (1 OAI, 4 VAI, 1 NAI)
Last OAI inspection
Feb 14, 2024
Warning letters
1 listed by FDA for this FEI, latest Sep 13, 2024

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 18, 2025Voluntary Action Indicated (VAI)Registration not updated (21 CFR 1.234)
Equipment - automated - calibrate, inspect (21 CFR 111.30(c))
Batch record - complete (21 CFR 111.255(b))
Components - representative samples (21 CFR 111.155(c)(1))
and 18 more
Feb 14, 2024Official Action Indicated (OAI)Hand-washing facilities (21 CFR 111.15(i))
Batch record - complete (21 CFR 111.255(b))
Metal, foreign material (21 CFR 111.365(i))
Packaging description, representative label (21 CFR 111.210(g))
and 10 more
Jan 15, 2020No Action Indicated (NAI)Batch record - complete (21 CFR 111.255(b))
In-process identity, purity, strength, composition (21 CFR 111.70(c)(1))
Written procedures - quality control operations (21 CFR 111.103)
Nov 9, 2018Voluntary Action Indicated (VAI)Equipment - maintain - general (21 CFR 111.27(d))
Batch record - complete (21 CFR 111.255(b))
In-process identity, purity, strength, composition (21 CFR 111.70(c)(1))
Written procedures - quality control operations (21 CFR 111.103)
and 1 more
Dec 1, 2016Voluntary Action Indicated (VAI)Batch record - initials; each step (21 CFR 111.260(j)(2))
Specifications met - verify; finished batch (21 CFR 111.75(c))
Written procedures - quality control operations (21 CFR 111.103)
Quality control operations - quarantine (21 CFR 111.120(e))
and 1 more
Jul 27, 2016Voluntary Action Indicated (VAI)Batch record - initials; each step (21 CFR 111.260(j)(2))
Packaging description, representative label (21 CFR 111.210(g))
Master manufacturing record - each batch (21 CFR 111.205(a))
Signature; review, approval, rejection; reprocessing (21 CFR 111.140(b)(2)(ii))

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
Far East Summit LLC
Location
Dexter, OR (US)
Source
inspections

Compliance actions

FDA data resources

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