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Ipsen Bioscience, Inc.

FDA Regulatory Profile

Ipsen Bioscience, Inc. has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
May 20, 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
Inspections3Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
May 20, 2025Cambridge, MADrugsNo Action Indicated (NAI)3008532848
Oct 19, 2023Cambridge, MADrugsNo Action Indicated (NAI)3018842619
Jul 17, 2015Cambridge, MADrugsVoluntary Action Indicated (VAI)3008532848

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 3008532848Cambridge, MA2May 20, 2025
FEI 3018842619Cambridge, MA1Oct 19, 2023

FDA data resources

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