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BioAgilytix Labs, LLC — FDA Facility Profile

FEI 3007929739

BioAgilytix Labs, LLC is an FDA-registered facility (FEI 3007929739) located in Durham, NC, US. Registered operations: ANALYSIS. RegDataLab tracks 4 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Jul 10, 2026: Voluntary Action Indicated (VAI)
Inspections on record
4 (1 VAI, 3 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
Jul 10, 2026Voluntary Action Indicated (VAI)No citations listed
Jul 27, 2018No Action Indicated (NAI)No citations listed
Apr 26, 2017No Action Indicated (NAI)No citations listed
Nov 20, 2014No Action Indicated (NAI)No citations listed

Facility details

Company
BioAgilytix Labs LLC
Location
Durham, NC (US)
Registration Expires
Dec 31, 2026
Operations
ANALYSIS
Source
decrs

FDA data resources

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