Similasan AG

FDA Regulatory Profile

Similasan AG has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest inspection
Apr 27, 2026 · 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
Inspections8Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Apr 27, 2026Jonen, SwitzerlandDrugsVoluntary Action Indicated (VAI)1000110034
Apr 4, 2023Jonen, SwitzerlandDrugsOfficial Action Indicated (OAI)1000110034
Sep 18, 2017Jonen, SwitzerlandDrugsNo Action Indicated (NAI)1000110034
Jul 23, 2015Jonen, SwitzerlandDrugsNo Action Indicated (NAI)1000110034
Nov 20, 2013Highlands Ranch, CODrugsNo Action Indicated (NAI)2026023
Sep 13, 2013Jonen, SwitzerlandDrugsVoluntary Action Indicated (VAI)1000110034
May 27, 2011Jonen, SwitzerlandDrugsVoluntary Action Indicated (VAI)1000110034
Apr 8, 2011Highlands Ranch, CODrugsOfficial Action Indicated (OAI)2026023

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 1000110034Jonen, Switzerland6Apr 27, 2026
FEI 2026023Highlands Ranch, CO2Nov 20, 2013

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