STERITECH, INC.

FDA Regulatory Profile

STERITECH, INC. has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Dec 8, 2023 · 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
Inspections6Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Related names

NameRecalls510(k)InspectionsComplianceMost recent recall
Steritech Pty
Same company group
0010—

Recent FDA Inspections

DateSiteProductClassificationFEI
Dec 8, 2023Salinas, PRDevicesNo Action Indicated (NAI)2648209
Nov 10, 2023Wetherill Park, AustraliaDrugsVoluntary Action Indicated (VAI)3005193435
Feb 10, 2021Salinas, PRDevicesVoluntary Action Indicated (VAI)2648209
Feb 19, 2019Salinas, PRDevicesVoluntary Action Indicated (VAI)2648209
Apr 26, 2017Salinas, PRDevicesNo Action Indicated (NAI)2648209
Dec 20, 2012Salinas, PRDevicesVoluntary Action Indicated (VAI)2648209

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 2648209Salinas, PR5Dec 8, 2023
FEI 3005193435Wetherill Park, Australia1Nov 10, 2023

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