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Barton-Carey Medical Products Inc FDA Inspection Record

FEI 1527179 · Inspections, Form 483s, warning letters and import refusals

Barton-Carey Medical Products Inc is an FDA-inspected facility (FEI 1527179) located in Maumee, OH, US. RegDataLab tracks 3 FDA inspections and 1 compliance action at this facility.

What FDA found at this site

Latest inspection
Mar 14, 2014: Voluntary Action Indicated (VAI)
Inspections on record
3 (1 OAI, 2 VAI)
Last OAI inspection
Aug 10, 2012
Warning letters
1 listed by FDA for this FEI, latest Dec 10, 2012

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
Mar 14, 2014Voluntary Action Indicated (VAI)No citations listed
Aug 10, 2012Official Action Indicated (OAI)Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Design changes - Lack of or Inadequate Procedures (21 CFR 820.30(i))
Lack of or inadequate procedures (21 CFR 820.100(a))
Review and evaluation for investigation (21 CFR 820.198(b))
and 4 more
Sep 4, 2009Voluntary Action Indicated (VAI)Documentation (21 CFR 820.75(a))
Lack of or inadequate procedures (21 CFR 820.100(a))
No release signature (21 CFR 820.80(d)(3))
No release authorization date (21 CFR 820.80(d)(4))
and 1 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 14, 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 VAIMar 14, 201410 years or older, so it adds no points0
Warning letter on FDA's dashboard, which does not show close-outsDec 10, 201210 years or older, so it adds no points0
Inspection classified OAIAug 10, 201210 years or older, so it adds no points0
Inspection classified VAISep 4, 200910 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
Barton-Carey Medical Products Inc
Location
Maumee, OH (US)
Source
inspections

Compliance actions

FDA data resources

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