Covenance Group LLC FDA Record

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

Covenance Group LLC has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Covenance Group LLC" is on file.

What these totals cover: FDA records filed under the name "Covenance Group LLC" and its spelling variant "Covenance Group".

Latest inspection
Mar 21, 2025 · VAI

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
Inspections2Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent FDA inspections

2 inspections on Mar 21, 2025.

DateSiteProductClassificationFEI
Mar 21, 2025Owenton, KYFood/CosmeticsVoluntary Action Indicated (VAI)3024742620
Mar 21, 2025Owenton, KYFood/CosmeticsNo Action Indicated (NAI)3024742620
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 3024742620Owenton, KY2Mar 21, 2025

Covenance Group LLC and the FDA: common questions

Has Covenance Group LLC received an FDA warning letter?

No FDA warning letter addressed to the name "Covenance Group LLC" 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 Covenance Group LLC received an FDA Form 483?

FDA has not published a Form 483 for "Covenance Group LLC" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Covenance Group LLC?

The most recent FDA inspection on file ended Mar 21, 2025 at Owenton, KY and was classified VAI. FDA has 2 inspections of Covenance Group LLC on file.

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