M.D.R. Fitness Corp. FDA Inspection Record

FEI 1000307762 · Inspections, Form 483s, warning letters and import refusals

M.D.R. Fitness Corp. is an FDA-inspected facility (FEI 1000307762) located in Sunrise, FL, US. RegDataLab tracks 5 FDA inspections and 1 compliance action at this facility.

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What FDA found at this site

Latest inspection
Oct 1, 2019: Voluntary Action Indicated (VAI)
Inspections on record
5 (4 VAI, 1 NAI)
Last OAI inspection
None on record
Warning letters
1 listed by FDA for this FEI, latest Jan 30, 2013
Import refusals
8

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
Oct 1, 2019Voluntary Action Indicated (VAI)No citations listed
Jul 28, 2016No Action Indicated (NAI)No citations listed
Sep 12, 2013Voluntary Action Indicated (VAI)No citations listed
Aug 3, 2012Voluntary Action Indicated (VAI)No citations listed
Aug 22, 2011Voluntary Action Indicated (VAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
Training--operations, GMPs, written procedures (21 CFR 211.25(a))
Label storage access limited to authorized personnel (21 CFR 211.122(d))
Quality control - packaged, labeled (21 CFR 111.65)
and 10 more

Facility details

Company
MDR Fitness Corp.
Location
Sunrise, FL (US)
Source
inspections

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