Sterigenics US, LLC, Charlotte, NC – FDA Inspections

Inspection records and compliance data for Sterigenics US, LLC in Charlotte, North Carolina. 12 FDA inspections on record, last inspected December 03, 2025.

Company Profile

This profile covers Sterigenics US, LLC based in Charlotte, North Carolina, United States.

FDA Inspection History

FDA inspections: 12
OAI: 0
VAI: 0
NAI: 11
Unclassified: 1
Form 483s: 0
Warning letters: 0

First inspected August 19, 2009. Last inspected December 3, 2025.

FDA inspections (12)

Date	Result	FDA center(s)	Insp. #
December 3, 2025	Not classified	Human Drugs	1294490
April 8, 2025	NAI	Biologics · Human Cellular, Tissue, and Gene Therapies	1266423
October 25, 2022	NAI	Medical Devices & Rad Health · Compliance: Devices	1190626
March 4, 2021	NAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	1137201
October 21, 2019	NAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	1106995
August 26, 2019	NAI	Human Drugs · Drug Quality Assurance	1106089
July 11, 2017	NAI	Biologics · Human Cellular, Tissue, and Gene Therapies	1019659
May 19, 2017	NAI	Medical Devices & Rad Health · Compliance: Devices	1023471
June 12, 2014	NAI	Biologics, Human Drugs · Human Cellular, Tissue, and Gene Therapies	883316
November 8, 2013	NAI	Medical Devices & Rad Health · Compliance: Devices	855463
August 12, 2011	NAI	Human Drugs, Medical Devices & Rad Health · Compliance: Devices	744639
August 19, 2009	NAI	Medical Devices & Rad Health · Compliance: Devices	607730

FDA documents

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

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