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Sterigenics US, LLC

FDA Regulatory Profile

Sterigenics US, LLC has 0 FDA recalls, 75 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Aug 13, 2026 · NAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections75Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Related names

NameRecalls510(k)InspectionsComplianceMost recent recall
Sterigenics U.S
Same company group		00690—

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 13, 2026Hayward, CABiologicsNo Action Indicated (NAI)3000215205
Jun 16, 2026Gilroy, CAFood/CosmeticsNo Action Indicated (NAI)3004784675
Mar 19, 2026West Memphis, ARDevicesNo Action Indicated (NAI)3002907620
Feb 24, 2026Fort Worth, TXFood/CosmeticsNo Action Indicated (NAI)3001236277
Dec 11, 2025Fort Worth, TXDevicesNo Action Indicated (NAI)3001236277
Dec 3, 2025Charlotte, NCDrugsNo Action Indicated (NAI)1000219637
Nov 7, 2025Atlanta, GADevicesNo Action Indicated (NAI)1018470
Jun 26, 2025Charlotte, NCDevicesNo Action Indicated (NAI)1000512168
May 28, 2025Lewis Center, OHBiologicsNo Action Indicated (NAI)1526534
Apr 8, 2025Charlotte, NCBiologicsNo Action Indicated (NAI)1000219637
Feb 28, 2025Grand Prairie, TXDevicesNo Action Indicated (NAI)3004111573
Sep 19, 2024Haw River, NCBiologicsNo Action Indicated (NAI)1036836
Feb 15, 2024Haw River, NCDevicesNo Action Indicated (NAI)1036836
Aug 17, 2023Fort Worth, TXDevicesVoluntary Action Indicated (VAI)3001236277
May 31, 2023Salem, NJDevicesNo Action Indicated (NAI)2245590
May 4, 2023West Memphis, ARDevicesVoluntary Action Indicated (VAI)3002907620
Oct 25, 2022Charlotte, NCDevicesNo Action Indicated (NAI)1000219637
Aug 23, 2022Fort Worth, TXDrugsVoluntary Action Indicated (VAI)3001236277
Jun 22, 2022Lewis Center, OHDevicesNo Action Indicated (NAI)1526534
Mar 4, 2021Charlotte, NCDevicesNo Action Indicated (NAI)1000219637

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3000215205Hayward, CA8Aug 13, 2026
FEI 3004784675Gilroy, CA2Jun 16, 2026
FEI 3002907620West Memphis, AR5Mar 19, 2026
FEI 3001236277Fort Worth, TX8Feb 24, 2026
FEI 1000219637Charlotte, NC12Dec 3, 2025
FEI 1018470Atlanta, GA6Nov 7, 2025
FEI 1000512168Charlotte, NC6Jun 26, 2025
FEI 1526534Lewis Center, OH6May 28, 2025
FEI 3004111573Grand Prairie, TX1Feb 28, 2025
FEI 1036836Haw River, NC7Sep 19, 2024
FEI 2245590Salem, NJ5May 31, 2023
FEI 1450293Willowbrook, IL6Jul 6, 2017
FEI 2022435Tustin, CA3Jan 20, 2016

FDA data resources

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