Windmill Health Products, LLC FDA Record

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

Windmill Health Products, LLC has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Windmill Health Products, LLC, the most recent on Oct 7, 2014.

What these totals cover: FDA records filed under the name "Windmill Health Products, LLC" and its spelling variant "Windmill Health Products".

Latest inspection
Apr 29, 2025 · NAI

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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 actions1Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

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

Windmill Health Products, LLC: FDA inspections per year 2017: 0 inspections020172018: 1 inspections120182019: 0 inspections020192020: 0 inspections020202021: 0 inspections020212022: 0 inspections020222023: 0 inspections020232024: 2 inspections220242025: 1 inspections120252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202510000
202420000
202300000
202200000
202100000
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.

Windmill Health Products, LLC FDA Warning Letters

1 warning letter on Oct 7, 2014.

IssuedSubjectIssuing officeClose-out letter
Oct 7, 2014

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 Jul 17, 2013 to Apr 29, 2025.

DateSiteProductClassificationFEI
Apr 29, 2025West Caldwell, NJFood/CosmeticsNo Action Indicated (NAI)3008515879
Jun 5, 2024West Caldwell, NJFood/CosmeticsNo Action Indicated (NAI)3008515879
May 28, 2024West Caldwell, NJFood/CosmeticsVoluntary Action Indicated (VAI)3008515879
Dec 19, 2018West Caldwell, NJFood/CosmeticsNo Action Indicated (NAI)3008515879
Oct 13, 2015West Caldwell, NJFood/CosmeticsNo Action Indicated (NAI)3008515879
Jul 17, 2013West Caldwell, NJFood/CosmeticsOfficial Action Indicated (OAI)3008515879
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 Windmill Health Products, LLC: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Oct 7, 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 3008515879West Caldwell, NJ6Apr 29, 2025

Windmill Health Products, LLC and the FDA: common questions

Has Windmill Health Products, LLC received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Windmill Health Products, LLC. The most recent is dated Oct 7, 2014.

Has Windmill Health Products, LLC received an FDA Form 483?

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

When did the FDA last inspect Windmill Health Products, LLC?

The most recent FDA inspection on file ended Apr 29, 2025 at West Caldwell, NJ and was classified NAI. FDA has 6 inspections of Windmill Health Products, LLC 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.