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Covenant Medical Center Inc. IRB FDA Inspection Record

FEI 1000160433 · Inspections, Form 483s, warning letters and import refusals

Covenant Medical Center Inc. IRB is an FDA-inspected facility (FEI 1000160433) located in Saginaw, MI, US. RegDataLab tracks 3 FDA inspections and 1 compliance action at this facility.

What FDA found at this site

Latest inspection
Jul 12, 2018: No Action Indicated (NAI)
Inspections on record
3 (1 OAI, 1 VAI, 1 NAI)
Last OAI inspection
Apr 20, 2011
Warning letters
1 listed by FDA for this FEI, latest Sep 7, 2011

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
Jul 12, 2018No Action Indicated (NAI)No citations listed
May 2, 2012Voluntary Action Indicated (VAI)Initial and continuing reviews (21 CFR 56.108(a)(1))
Minutes of IRB meetings (21 CFR 56.115(a)(2))
Apr 20, 2011Official Action Indicated (OAI)Procedures, identification of those which were experimental (21 CFR 50.25(a)(1))
Consent form not approved/signed/dated (21 CFR 50.27(a))
Conflict of interest (21 CFR 56.107(e))
Initial and continuing reviews (21 CFR 56.108(a)(1))
and 11 more

FDA record score

0 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 VAIMay 2, 201210 years or older, so it adds no points0
Warning letter on FDA's dashboard, which does not show close-outsSep 7, 201110 years or older, so it adds no points0
Inspection classified OAIApr 20, 201110 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 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 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 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Covenant Medical Center Inc. IRB
Location
Saginaw, MI (US)
Source
inspections

Compliance actions

FDA data resources

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