Isomedix Operations Inc., Sandy, UT – FDA Inspections

Inspection records and compliance data for Isomedix Operations Inc. in Sandy, Utah. 7 FDA inspections on record, last inspected May 15, 2025.

Company Profile

This profile covers Isomedix Operations Inc. based in Sandy, Utah, United States.

FDA Inspection History

FDA inspections: 7
OAI: 0
VAI: 1
NAI: 5
Unclassified: 1
Form 483s: 0
Warning letters: 0

First inspected February 22, 2010. Last inspected May 15, 2025.

Most cited issue areas

SOPs not followed / documented1 inspection

FDA inspections (7)

Date	Result	FDA center(s)	Insp. #
May 15, 2025	Not classified	Biologics	1269908
July 2, 2019	NAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	1095335
November 27, 2018	NAI	Biologics · Human Cellular, Tissue, and Gene Therapies	1077482
February 13, 2015	NAI	Biologics, Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance	914481
March 21, 2012	VAI	Biologics, Human Drugs, Medical Devices & Rad Health · Compliance: Devices	774053
March 11, 2011	NAI	Biologics, Medical Devices & Rad Health · Human Cellular, Tissue, and Gene Therapies	714109
February 22, 2010	NAI	Human Drugs, Medical Devices & Rad Health · Compliance: Devices	654082

FDA documents

No Form 483s, Warning Letters or EIRs on record.

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