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Steris Applied Sterilization Technologies ULC

FDA Regulatory Profile

Steris Applied Sterilization Technologies ULC has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
May 14, 2025 · NAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections7Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
May 14, 2025Whitby, CanadaDrugsNo Action Indicated (NAI)3002807308
Nov 21, 2024Whitby, CanadaDevicesVoluntary Action Indicated (VAI)3002807308
Apr 17, 2019Whitby, CanadaDrugsNo Action Indicated (NAI)3002807308
Sep 12, 2014Whitby, CanadaDrugsNo Action Indicated (NAI)3002807308
Jun 28, 2012Whitby, CanadaDrugsVoluntary Action Indicated (VAI)3002807308
Aug 12, 2009Whitby, CanadaDrugsNo Action Indicated (NAI)3002807308
Apr 30, 2009Whitby, CanadaDevicesNo Action Indicated (NAI)3002807308

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.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3002807308Whitby, Canada7May 14, 2025

FDA data resources

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