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Innovis Health, LLC D.B.A. Essentia Health FDA Record

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

Latest inspection VAI · Jun 11, 2025
No warning letters matched by name

Inspections 5

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

Innovis Health, LLC D.B.A. Essentia Health has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Innovis Health, LLC D.B.A. Essentia Health" is on file. FDA has published 1 Form 483 for Innovis Health, LLC D.B.A. Essentia Health.

What these totals cover: FDA records filed under the name "Innovis Health, LLC D.B.A. Essentia Health".

Latest inspection: Jun 11, 2025 · VAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 11, 2026 (checked Nov 15, 2026, unchanged)	File dated Nov 10, 2026	Current
510(k) clearances	0	Nov 15, 2026	File dated Nov 9, 2026	Current
Inspections	5	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Innovis Health, LLC D.B.A. Essentia Health's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Innovis Health, LLC D.B.A. Essentia Health: FDA inspections per year

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	1	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	1	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	0	0	0	0	0
2018	1	0	0	0	0
2017	0	0	0	0	0

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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Innovis Health, LLC D.B.A. Essentia Health Form 483s

1 Form 483 published by FDA.

Date	Document	FEI
Jun 11, 2025 · Document on fda.gov	483	3003169765

A Form 483 lists the observations FDA investigators made at the end of an inspection. FDA publishes some Form 483s in its reading room, and each date links to that document. Read the observations with the FDA 483 search.

Recent FDA inspections

5 inspections from Jun 25, 2014 to Jun 11, 2025.

Date	Site	Product	Classification	FEI
Jun 11, 2025	Fargo, ND	Biologics	Voluntary Action Indicated (VAI)	3003169765
May 25, 2022	Fargo, ND	Biologics	No Action Indicated (NAI)	3003169765
Mar 23, 2018	Fargo, ND	Biologics	No Action Indicated (NAI)	3003169765
May 5, 2016	Fargo, ND	Biologics	No Action Indicated (NAI)	3003169765
Jun 25, 2014	Fargo, ND	Biologics	No Action Indicated (NAI)	3003169765

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.

Facility	Location	Inspections	Latest
FEI 3003169765	Fargo, ND	5	Jun 11, 2025

Innovis Health, LLC D.B.A. Essentia Health and the FDA: common questions

Has Innovis Health, LLC D.B.A. Essentia Health received an FDA warning letter?

No FDA warning letter addressed to the name "Innovis Health, LLC D.B.A. Essentia Health" 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 Innovis Health, LLC D.B.A. Essentia Health received an FDA Form 483?

FDA has published 1 Form 483 for Innovis Health, LLC D.B.A. Essentia Health in its reading room, the most recent dated Jun 11, 2025. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Innovis Health, LLC D.B.A. Essentia Health?

The most recent FDA inspection on file ended Jun 11, 2025 at Fargo, ND and was classified VAI. FDA has 5 inspections of Innovis Health, LLC D.B.A. Essentia Health on file.

Need more than this page shows? Ask about Innovis Health, LLC D.B.A. Essentia Health in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.