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Ionetix Corporation — FDA Facility Profile

FEI 3016458643

Ionetix Corporation is an FDA-registered facility (FEI 3016458643) located in El Paso, TX, US. Registered operations: POSITRON EMISSION TOMOGRAPHY DRUG PRODUCTION. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
Sep 14, 2023: Voluntary Action Indicated (VAI)
Inspections on record
1 (1 VAI)
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
Sep 14, 2023Voluntary Action Indicated (VAI)Lab sampling and test procedures (21 CFR 212.60(b))
Orderly handling, prevention of mix-ups, prevention of contamination (21 CFR 212.30(a))

Facility details

Company
Ionetix Corporation
Location
El Paso, TX (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.