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Valley Health/Winchester Medical Center IRB FDA Inspection Record

FEI 1121588 · Inspections, Form 483s, warning letters and import refusals

Valley Health/Winchester Medical Center IRB is an FDA-inspected facility (FEI 1121588) located in Winchester, VA, US. RegDataLab tracks 4 FDA inspections and 1 compliance action at this facility.

What FDA found at this site

Latest inspection
Aug 9, 2022: Voluntary Action Indicated (VAI)
Inspections on record
4 (1 OAI, 2 VAI, 1 NAI)
Last OAI inspection
Feb 1, 2013
Warning letters
1 listed by FDA for this FEI, latest May 9, 2013

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
Aug 9, 2022Voluntary Action Indicated (VAI)No IRB notification of significant risk determination (21 CFR 812.66)
Minutes of IRB meetings (21 CFR 56.115(a)(2))
List of members (21 CFR 56.115(a)(5))
Apr 28, 2015No Action Indicated (NAI)No citations listed
Feb 1, 2013Official Action Indicated (OAI)Minor changes (21 CFR 56.110(b)(2))
Method to keep members advised (21 CFR 56.110(c))
Nov 12, 2008Voluntary Action Indicated (VAI)Minor changes (21 CFR 56.110(b)(2))
Method to keep members advised (21 CFR 56.110(c))

FDA record score

4 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 15, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

4 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIAug 9, 20226 x 0.63.6
Warning letter on FDA's dashboard, which does not show close-outsMay 9, 201310 years or older, so it adds no points0
Inspection classified OAIFeb 1, 201310 years or older, so it adds no points0
Inspection classified VAINov 12, 200810 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 15, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 15, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 15, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 15, 2026Newest record Nov 5, 2026Current

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Facility details

Company
Valley Health/Winchester Medical Center IRB
Location
Winchester, VA (US)
Source
inspections

Compliance actions

FDA data resources

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