EMPWR USA Inc

FDA Regulatory Profile

EMPWR USA Inc 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 "EMPWR USA Inc" and its spelling variant "Empwr Usa".

Latest inspection
Nov 2, 2023 · 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

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

EMPWR USA Inc: FDA inspections per year 2017: 0 inspections020172018: 2 inspections220182019: 0 inspections020192020: 0 inspections020202021: 0 inspections020212022: 0 inspections020222023: 3 inspections320232024: 0 inspections020242025: 0 inspections020252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500000
202400000
202330000
202200000
202100000
202000000
201900000
201820000
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.

Recent FDA inspections

9 inspections from Jan 5, 2009 to Nov 2, 2023.

DateSiteProductClassificationFEI
Nov 2, 2023Mcminnville, ORFood/CosmeticsNo Action Indicated (NAI)3010694765
Jun 20, 2023Mcminnville, ORFood/CosmeticsNo Action Indicated (NAI)3010694765
Mar 9, 2023Mcminnville, ORFood/CosmeticsNo Action Indicated (NAI)3024245
Dec 13, 2018Mcminnville, ORFood/CosmeticsNo Action Indicated (NAI)3010694765
Nov 28, 2018Mcminnville, ORFood/CosmeticsNo Action Indicated (NAI)3024245
Mar 5, 2014Mcminnville, ORFood/CosmeticsVoluntary Action Indicated (VAI)3024245
Apr 27, 2010Mcminnville, ORFood/CosmeticsNo Action Indicated (NAI)3024245
Mar 4, 2009Mcminnville, ORFood/CosmeticsNo Action Indicated (NAI)3024245
Jan 5, 2009Mcminnville, ORFood/CosmeticsNo Action Indicated (NAI)3024245
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

2 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3010694765Mcminnville, OR3Nov 2, 2023
FEI 3024245Mcminnville, OR6Mar 9, 2023

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