EnerHealth Botanicals LLC FDA Record

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

EnerHealth Botanicals LLC has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "EnerHealth Botanicals LLC" is on file.

What these totals cover: FDA records filed under the name "EnerHealth Botanicals LLC" and its spelling variant "Enerhealth Botanicals".

Latest inspection
Aug 15, 2024 · 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
Inspections3Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

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

EnerHealth Botanicals LLC: FDA inspections per year 2017: 0 inspections020172018: 1 inspections120182019: 0 inspections020192020: 0 inspections020202021: 1 inspections120212022: 0 inspections020222023: 0 inspections020232024: 1 inspections120242025: 0 inspections020252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500000
202410000
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

3 inspections from Mar 5, 2018 to Aug 15, 2024.

DateSiteProductClassificationFEI
Aug 15, 2024Mead, COFood/CosmeticsNo Action Indicated (NAI)3014251786
Jan 28, 2021Mead, COFood/CosmeticsNo Action Indicated (NAI)3014251786
Mar 5, 2018Mead, COFood/CosmeticsVoluntary Action Indicated (VAI)3014251786
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 3014251786Mead, CO3Aug 15, 2024

EnerHealth Botanicals LLC and the FDA: common questions

Has EnerHealth Botanicals LLC received an FDA warning letter?

No FDA warning letter addressed to the name "EnerHealth Botanicals 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 EnerHealth Botanicals LLC received an FDA Form 483?

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

When did the FDA last inspect EnerHealth Botanicals LLC?

The most recent FDA inspection on file ended Aug 15, 2024 at Mead, CO and was classified NAI. FDA has 3 inspections of EnerHealth Botanicals LLC on file.

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