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OMNILIFE USA

FDA Regulatory Profile

OMNILIFE USA has 0 FDA recalls, 9 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "OMNILIFE USA".

Latest inspection
Mar 9, 2026 · NAI

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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
Inspections9Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

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

OMNILIFE USA: FDA inspections per year 2017: 2 inspections220172018: 0 inspections020182019: 0 inspections020192020: 1 inspections120202021: 0 inspections020212022: 1 inspections120222023: 1 inspections120232024: 0 inspections020242025: 0 inspections020252026: 2 inspections22026
YearInspectionsOAIWarning lettersRecall recordsClass I
202620000
202500000
202400000
202310000
202210000
202100000
202010000
201900000
201800000
201720000

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.

Recent FDA inspections

9 inspections from Sep 11, 2015 to Mar 9, 2026.

DateSiteProductClassificationFEI
Mar 9, 2026Plano, TXFood/CosmeticsNo Action Indicated (NAI)3023762191
Jan 9, 2026Irving, TXFood/CosmeticsNo Action Indicated (NAI)3012907331
Apr 28, 2023San Jose, CAFood/CosmeticsVoluntary Action Indicated (VAI)3011096836
Sep 6, 2022Dallas, TXFood/CosmeticsVoluntary Action Indicated (VAI)3013429410
Jun 9, 2020Dallas, TXFood/CosmeticsVoluntary Action Indicated (VAI)3013429410
Sep 8, 2017San Jose, CAFood/CosmeticsNo Action Indicated (NAI)3011096836
Sep 1, 2017Commerce, CAFood/CosmeticsVoluntary Action Indicated (VAI)3004341671
Jun 10, 2016Chino, CAFood/CosmeticsNo Action Indicated (NAI)3004941833
Sep 11, 2015Cicero, ILFood/CosmeticsNo Action Indicated (NAI)3010012381
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

7 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3023762191Plano, TX1Mar 9, 2026
FEI 3012907331Irving, TX1Jan 9, 2026
FEI 3011096836San Jose, CA2Apr 28, 2023
FEI 3013429410Dallas, TX2Sep 6, 2022
FEI 3004341671Commerce, CA1Sep 1, 2017
FEI 3004941833Chino, CA1Jun 10, 2016
FEI 3010012381Cicero, IL1Sep 11, 2015

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FDA data resources

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