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SIGMAGRAFT, INC. FDA Inspection Record

FEI 3009598981 · Inspections, Form 483s, warning letters and import refusals

SIGMAGRAFT, INC. is an FDA-registered facility (FEI 3009598981) located in Fullerton, CA, US. RegDataLab tracks 4 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Apr 25, 2025: Voluntary Action Indicated (VAI)
Inspections on record
4 (1 OAI, 1 VAI, 2 NAI)
Last OAI inspection
Feb 11, 2014
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
Apr 25, 2025Voluntary Action Indicated (VAI)Procedures and release criteria (21 CFR 1271.265(e))
Mar 7, 2019No Action Indicated (NAI)No citations listed
Feb 11, 2014Official Action Indicated (OAI)No sponsor report in response to a request (21 CFR 812.150(b)(10))
May 2, 2011No Action Indicated (NAI)No citations listed

Facility details

Company
SigmaGraft Inc
Location
Fullerton, CA (US)
Source
device

FDA data resources

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