CareHealth America FDA Record

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

  • Latest inspection NAI · Jan 25, 2024
  • Last warning letter 2014
Inspections 6 2 OAI
Recalls 0 0 Class I
Warning letters 3 Latest Sep 17, 2014
510(k) clearances 0 None on file

CareHealth America has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 3 compliance actions on record. FDA has issued 3 warning letters to CareHealth America, the most recent on Sep 17, 2014.

What these totals cover: FDA records filed under the name "CareHealth America".

Latest inspection
Jan 25, 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
Inspections6Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions3Nov 2, 2026Newest record Oct 29, 2026Current

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CareHealth America FDA Warning Letters

3 warning letters from Mar 12, 2009 to Sep 17, 2014.

IssuedSubjectIssuing officeClose-out letter
Sep 17, 2014 · Record page
Mar 24, 2011 · Record page
Mar 12, 2009 · Record page

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent FDA inspections

6 inspections from Oct 29, 2008 to Jan 25, 2024.

DateSiteProductClassificationFEI
Jan 25, 2024Blue Earth, MNDevicesNo Action Indicated (NAI)3014946040
Sep 25, 2015Blue Earth, MNDevicesNo Action Indicated (NAI)3014946040
Jun 24, 2014Blue Earth, MNDevicesOfficial Action Indicated (OAI)3014946040
Jul 13, 2011Blue Earth, MNDevicesVoluntary Action Indicated (VAI)3014946040
Jan 20, 2011Blue Earth, MNDevicesOfficial Action Indicated (OAI)3014946040
Oct 29, 2008Blue Earth, MNDevicesVoluntary Action Indicated (VAI)3014946040
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.

Compliance Actions

FDA's compliance actions data lists 3 compliance actions under CareHealth America: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Sep 17, 2014.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3014946040Blue Earth, MN6Jan 25, 2024

CareHealth America and the FDA: common questions

Has CareHealth America received an FDA warning letter?

Yes. FDA has issued 3 warning letters to CareHealth America. The most recent is dated Sep 17, 2014.

Has CareHealth America received an FDA Form 483?

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

When did the FDA last inspect CareHealth America?

The most recent FDA inspection on file ended Jan 25, 2024 at Blue Earth, MN and was classified NAI. FDA has 6 inspections of CareHealth America on file, 2 of them classified OAI (official action indicated).

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