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Biokosmes Srl

FDA Regulatory Profile

Biokosmes Srl has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jun 26, 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
Inspections5Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 26, 2026Bosisio Parini, ItalyDrugsVoluntary Action Indicated (VAI)3005488444
Dec 2, 2022Bosisio Parini, ItalyDrugsVoluntary Action Indicated (VAI)3005488444
Sep 22, 2017Bosisio Parini, ItalyDrugsVoluntary Action Indicated (VAI)3005488444
May 29, 2014Bosisio Parini, ItalyDevicesNo Action Indicated (NAI)3005488444
Nov 18, 2010Bosisio Parini, ItalyDevicesVoluntary Action Indicated (VAI)3005488444

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 3005488444Bosisio Parini, Italy5Jun 26, 2026

FDA data resources

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