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STAT MEDICAL DEVICES, INC. FDA Inspection Record

FEI 1000525253 · Inspections, Form 483s, warning letters and import refusals

STAT MEDICAL DEVICES, INC. is an FDA-registered facility (FEI 1000525253) located in North Miami Beach, FL, US. RegDataLab tracks 7 FDA inspections and 2 compliance actions at this facility.

What FDA found at this site

Latest inspection
Mar 18, 2025: Voluntary Action Indicated (VAI)
Inspections on record
7 (2 OAI, 3 VAI, 2 NAI)
Last OAI inspection
Aug 21, 2013
Warning letters
2 listed by FDA for this FEI, latest Jul 23, 2015

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 18, 2025Voluntary Action Indicated (VAI)Label to bear a unique device identifier (21 CFR 801.20(a))
Design control - no procedures (21 CFR 820.30(a))
Nonconforming product, Lack of or inadequate procedures (21 CFR 820.90(a))
Training records (21 CFR 820.25(b))
Nov 7, 2022No Action Indicated (NAI)Training - Lack of or inadequate procedures (21 CFR 820.25(b))
Purchasing controls, Lack of or inadequate procedures (21 CFR 820.50)
May 20, 2016Voluntary Action Indicated (VAI)Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Lack of or inadequate procedures (21 CFR 820.100(a))
Individual Report of Malfunction (21 CFR 803.50(a)(2))
Feb 20, 2015Voluntary Action Indicated (VAI)Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Documentation (21 CFR 820.100(b))
Evaluation of suppliers, contractors, etc., requirements (21 CFR 820.50(a))
Individual Report of Malfunction (21 CFR 803.50(a)(2))
Aug 21, 2013Official Action Indicated (OAI)Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Lack of or inadequate procedures (21 CFR 820.100(a))
Lack of or inadequate organizational structure (21 CFR 820.20(b))
Evaluation of suppliers, contractors, etc., requirements (21 CFR 820.50(a))
and 1 more
Feb 18, 2010No Action Indicated (NAI)No citations listed
Dec 5, 2008Official Action Indicated (OAI)Design verification procedures (21 CFR 820.30(f))
Documentation (21 CFR 820.75(a))
Results of investigation (21 CFR 820.198(e)(6))
Design verification - documentation (21 CFR 820.30(f))
and 4 more

FDA record score

6 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.

7 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIMar 18, 20256 x 16
Inspection classified VAIMay 20, 201610 years or older, so it adds no points0
Warning letter on FDA's dashboard, which does not show close-outsJul 23, 201510 years or older, so it adds no points0
Inspection classified VAIFeb 20, 201510 years or older, so it adds no points0
Inspection classified OAIAug 21, 201310 years or older, so it adds no points0
Warning letter on FDA's dashboard, which does not show close-outsApr 17, 200910 years or older, so it adds no points0
Inspection classified OAIDec 5, 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 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
Stat Medical Devices, Inc.
Location
North Miami Beach, FL (US)
Source
device

Compliance actions

FDA data resources

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