Ozark Empire Distributors, Inc. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Ozark Empire Distributors, Inc. has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Ozark Empire Distributors, Inc." is on file.

What these totals cover: FDA records filed under the name "Ozark Empire Distributors, Inc." and its spelling variant "Ozark Empire Distributors".

Latest inspection
Apr 7, 2025 · NAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections5Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Ozark Empire Distributors, Inc.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Ozark Empire Distributors, Inc.: FDA inspections per year 2017: 0 inspections020172018: 1 inspections120182019: 0 inspections020192020: 0 inspections020202021: 1 inspections120212022: 0 inspections020222023: 0 inspections020232024: 0 inspections020242025: 1 inspections120252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202510000
202400000
202300000
202200000
202110000
202000000
201900000
201810000
201700000

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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Recent FDA inspections

5 inspections from Aug 2, 2012 to Apr 7, 2025.

DateSiteProductClassificationFEI
Apr 7, 2025Rogers, ARFood/CosmeticsNo Action Indicated (NAI)2315117
Nov 3, 2021Rogers, ARFood/CosmeticsVoluntary Action Indicated (VAI)2315117
Jun 4, 2018Rogers, ARFood/CosmeticsNo Action Indicated (NAI)2315117
Oct 20, 2014Rogers, ARFood/CosmeticsNo Action Indicated (NAI)2315117
Aug 2, 2012Rogers, ARFood/CosmeticsNo Action Indicated (NAI)2315117
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 2315117Rogers, AR5Apr 7, 2025

Ozark Empire Distributors, Inc. and the FDA: common questions

Has Ozark Empire Distributors, Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "Ozark Empire Distributors, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Ozark Empire Distributors, Inc. received an FDA Form 483?

FDA has not published a Form 483 for "Ozark Empire Distributors, Inc." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Ozark Empire Distributors, Inc.?

The most recent FDA inspection on file ended Apr 7, 2025 at Rogers, AR and was classified NAI. FDA has 5 inspections of Ozark Empire Distributors, Inc. on file.

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