Luv N' Care, Ltd. FDA Record

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

Luv N' Care, Ltd. has 0 FDA recalls, 3 inspections, 2 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Luv N' Care, Ltd., the most recent on Sep 11, 2009.

What these totals cover: FDA records filed under the name "Luv N' Care, Ltd." and its spelling variant "Luv N' Care".

Latest inspection
Feb 4, 2015 · NAI
Latest 510(k)
Mar 24, 2010

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances2Nov 8, 2026File dated Nov 2, 2026Current
Inspections3Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

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Luv N' Care, Ltd. FDA Warning Letters

1 warning letter on Sep 11, 2009.

IssuedSubjectIssuing officeClose-out letter
Sep 11, 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

3 inspections from Sep 9, 2010 to Feb 4, 2015.

DateSiteProductClassificationFEI
Feb 4, 2015Monroe, LAFood/CosmeticsNo Action Indicated (NAI)2381321
Oct 26, 2012Monroe, LADevicesVoluntary Action Indicated (VAI)2381321
Sep 9, 2010Monroe, LADevicesOfficial Action Indicated (OAI)2381321
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 1 compliance action under Luv N' Care, Ltd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Sep 11, 2009.

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 2381321Monroe, LA3Feb 4, 2015

Recent 510(k) clearances

2 510(k) clearances from Mar 1, 2010 to Mar 24, 2010.

K-NumberDeviceDate
K100385NUBY NATURAL TOUCH RHYTHM DUAL ACTION ELECTRIC BREAST PUMPMar 24, 2010
K092494GEL FILLED GUM SOOTHERMar 1, 2010

Luv N' Care, Ltd. and the FDA: common questions

Has Luv N' Care, Ltd. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Luv N' Care, Ltd.. The most recent is dated Sep 11, 2009.

Has Luv N' Care, Ltd. received an FDA Form 483?

FDA has not published a Form 483 for "Luv N' Care, Ltd." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Luv N' Care, Ltd.?

The most recent FDA inspection on file ended Feb 4, 2015 at Monroe, LA and was classified NAI. FDA has 3 inspections of Luv N' Care, Ltd. on file, 1 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.