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INFINIUM MEDICAL, INC. FDA Inspection Record

FEI 3007513035 · Inspections, Form 483s, warning letters and import refusals

INFINIUM MEDICAL, INC. is an FDA-registered facility (FEI 3007513035) located in Largo, FL, US. RegDataLab tracks 4 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Nov 8, 2023: Voluntary Action Indicated (VAI)
Inspections on record
4 (3 VAI, 1 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Recalls as the recalling firm
1, latest May 31, 2019

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
Nov 8, 2023Voluntary Action Indicated (VAI)Service reports/MDRs/complaints (21 CFR 820.200(c))
Individual Report of Malfunction (21 CFR 803.50(a)(2))
May 15, 2019Voluntary Action Indicated (VAI)Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Lack of or inadequate procedures (21 CFR 820.100(a))
DMR - not or inadequately maintained (21 CFR 820.181)
Purchasing controls, Lack of or inadequate procedures (21 CFR 820.50)
and 1 more
Sep 4, 2015No Action Indicated (NAI)No citations listed
Oct 15, 2012Voluntary Action Indicated (VAI)Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Lack of or inadequate procedures (21 CFR 820.100(a))
DMR - not or inadequately maintained (21 CFR 820.181)
Maintained (21 CFR 820.198(e))

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
May 31, 2019Class IIZ-1926-2019CLEO Patient Monitor /Tranquility VS Patient Monitor
The CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the United States did not include the temperature monitor accessory…

Facility details

Company
Infinium Medical, Inc
Location
Largo, FL (US)
Source
device

FDA data resources

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