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Kitron AB

FDA Regulatory Profile

Kitron AB has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Nov 10, 2022 · VAI

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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
Inspections2Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Nov 10, 2022Jonkoping, SwedenDevicesVoluntary Action Indicated (VAI)3009834076
Dec 13, 2018Jonkoping, SwedenDevicesOfficial Action Indicated (OAI)3009834076

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 3009834076Jonkoping, Sweden2Nov 10, 2022

FDA data resources

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