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Defibtech Branford — FDA Facility Profile

FEI 3012972516

Defibtech Branford is an FDA-registered facility (FEI 3012972516) located in Branford, CT, US. RegDataLab tracks 2 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Mar 25, 2025: Voluntary Action Indicated (VAI)
Inspections on record
2 (1 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

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 25, 2025Voluntary Action Indicated (VAI)Lack of or inadequate complaint procedures (21 CFR 820.198(a))
GUDID Information required for unique device identification. (21 CFR 830.310(b))
Lack of or inadequate procedures (21 CFR 820.100(a))
Nonconforming product, Lack of or inadequate procedures (21 CFR 820.90(a))
and 1 more
Aug 16, 2017No Action Indicated (NAI)No citations listed

Facility details

Company
Defibtech, LLC
Location
Branford, CT (US)
Source
device

FDA data resources

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