Gaia Herbs Inc FDA Record

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

  • Latest inspection NAI · Aug 27, 2026
  • No warning letters matched by name
Inspections 9 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 0 None on file

Gaia Herbs Inc has 0 FDA recalls, 9 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Gaia Herbs Inc" is on file.

What these totals cover: FDA records filed under the name "Gaia Herbs Inc" and its spelling variant "Gaia Herbs".

Latest inspection
Aug 27, 2026 · 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
Inspections9Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

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

Gaia Herbs Inc: FDA inspections per year

YearInspectionsOAIWarning lettersRecall recordsClass I
202610000
202500000
202400000
202300000
202220000
202100000
202000000
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.

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Recent FDA inspections

9 inspections from Dec 12, 2011 to Aug 27, 2026.

DateSiteProductClassificationFEI
Aug 27, 2026Mills River, NCFood/CosmeticsNo Action Indicated (NAI)3015491694
Nov 21, 2022Brevard, NCFood/CosmeticsNo Action Indicated (NAI)3000274661
Jun 30, 2022Brevard, NCFood/CosmeticsNo Action Indicated (NAI)3000274661
Jun 30, 2017Brevard, NCFood/CosmeticsVoluntary Action Indicated (VAI)3000274661
Jun 30, 2017Brevard, NCFood/CosmeticsNo Action Indicated (NAI)3009285316
Aug 21, 2014Brevard, NCDrugsVoluntary Action Indicated (VAI)3000274661
Aug 18, 2014Brevard, NCFood/CosmeticsNo Action Indicated (NAI)3009285316
Dec 16, 2011Brevard, NCFood/CosmeticsVoluntary Action Indicated (VAI)3000274661
Dec 12, 2011Brevard, NCFood/CosmeticsVoluntary Action Indicated (VAI)3009285316
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

3 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3015491694Mills River, NC1Aug 27, 2026
FEI 3000274661Brevard, NC5Nov 21, 2022
FEI 3009285316Brevard, NC3Jun 30, 2017

Gaia Herbs Inc and the FDA: common questions

Has Gaia Herbs Inc received an FDA warning letter?

No FDA warning letter addressed to the name "Gaia Herbs 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 Gaia Herbs Inc received an FDA Form 483?

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

When did the FDA last inspect Gaia Herbs Inc?

The most recent FDA inspection on file ended Aug 27, 2026 at Mills River, NC and was classified NAI. FDA has 9 inspections of Gaia Herbs Inc on file.

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