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Ionetix Corporation — FDA Facility Profile

FEI 3015287791

Ionetix Corporation is an FDA-registered facility (FEI 3015287791) located in Jenkintown, PA, US. Registered operations: POSITRON EMISSION TOMOGRAPHY DRUG PRODUCTION. RegDataLab tracks 2 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Jul 23, 2026: 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
Jul 23, 2026Voluntary Action Indicated (VAI)Non-Conforming Product Investigation Incomplete (21 CFR 212.71(a))
Jun 30, 2021No Action Indicated (NAI)No citations listed

Facility details

Company
Ionetix Corporation
Location
Jenkintown, PA (US)
Registration Expires
Dec 31, 2027
Operations
POSITRON EMISSION TOMOGRAPHY DRUG PRODUCTION
Source
decrs

FDA data resources

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