Windmill Health Products, LLC FDA Inspection Record

FEI 3008515879 · Inspections, Form 483s, warning letters and import refusals

Windmill Health Products, LLC is an FDA-inspected facility (FEI 3008515879) located in West Caldwell, NJ, US. RegDataLab tracks 6 FDA inspections and 1 compliance action at this facility.

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What FDA found at this site

Latest inspection
Apr 29, 2025: No Action Indicated (NAI)
Inspections on record
6 (1 OAI, 1 VAI, 4 NAI)
Last OAI inspection
Jul 17, 2013
Warning letters
1 listed by FDA for this FEI, latest Oct 7, 2014

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Apr 29, 2025No Action Indicated (NAI)No citations listed
Jun 5, 2024No Action Indicated (NAI)No citations listed
May 28, 2024Voluntary Action Indicated (VAI)Develop FSVP (21 CFR 1.502(a))
Dec 19, 2018No Action Indicated (NAI)No citations listed
Oct 13, 2015No Action Indicated (NAI)No citations listed
Jul 17, 2013Official Action Indicated (OAI)Hold - temperature, humidity, light (21 CFR 111.455(a))
Written procedures - holding; distributing (21 CFR 111.475(b)(1))
Examination, testing; appropriate (21 CFR 111.320(a))
Specifications met - component identity (21 CFR 111.73)
and 5 more

Facility details

Company
Windmill Health Products, LLC
Location
West Caldwell, NJ (US)
Source
inspections

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