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Santa Clara Valley Medical Center IRB FDA Inspection Record

FEI 1000100855 · Inspections, Form 483s, warning letters and import refusals

Santa Clara Valley Medical Center IRB is an FDA-inspected facility (FEI 1000100855) located in San Jose, CA, US. RegDataLab tracks 4 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Jun 3, 2021: Voluntary Action Indicated (VAI)
Inspections on record
4 (1 OAI, 2 VAI, 1 NAI)
Last OAI inspection
Sep 19, 2014
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name

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
Jun 3, 2021Voluntary Action Indicated (VAI)List of members (21 CFR 56.115(a)(5))
Apr 11, 2016Voluntary Action Indicated (VAI)Minutes of IRB meetings (21 CFR 56.115(a)(2))
Sep 19, 2014Official Action Indicated (OAI)Prompt reporting of unanticipated problems (21 CFR 56.108(b)(1))
Prompt reporting of noncompliance (21 CFR 56.108(b)(2))
More frequent reviews, verification of no changes (21 CFR 56.108(a)(2))
Children as subjects (21 CFR 56.111(c))
and 2 more
Jul 17, 2009No Action Indicated (NAI)No citations listed

FDA record score

2 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.

3 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIJun 3, 20216 x 0.251.5
Inspection classified VAIApr 11, 201610 years or older, so it adds no points0
Inspection classified OAISep 19, 201410 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
Santa Clara Valley Medical Center IRB
Location
San Jose, CA (US)
Source
inspections

FDA data resources

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