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ICON PLC

FDA Regulatory Profile

ICON PLC has 0 FDA recalls, 26 inspections, 0 510(k) clearances and 2 compliance actions on record.

Latest inspection
May 22, 2026 · NAI

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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
Inspections26Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions2Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
May 22, 2026Blue Bell, PADrugsNo Action Indicated (NAI)3003494567
May 20, 2026Blue Bell, PADrugsNo Action Indicated (NAI)3003494567
Nov 25, 2025Blue Bell, PADrugsVoluntary Action Indicated (VAI)3003494567
Oct 24, 2025Assen, NetherlandsDrugsVoluntary Action Indicated (VAI)3038011239
Jul 2, 2025Dublin, IrelandDrugsNo Action Indicated (NAI)3016465959
Mar 27, 2025Blue Bell, PADrugsNo Action Indicated (NAI)3003494567
Feb 28, 2025Raleigh, NCDrugsVoluntary Action Indicated (VAI)3013747223
May 24, 2024Dublin, IrelandDrugsNo Action Indicated (NAI)3016465959
Jan 11, 2024Blue Bell, PADrugsNo Action Indicated (NAI)3003494567
Nov 4, 2022Lenexa, KSDrugsNo Action Indicated (NAI)3007467677
Feb 28, 2022Raleigh, NCDrugsNo Action Indicated (NAI)3013747223
Dec 16, 2021Blue Bell, PADrugsVoluntary Action Indicated (VAI)3003494567
Jun 24, 2021Blue Bell, PADrugsNo Action Indicated (NAI)3003494567
Sep 25, 2020Raleigh, NCDrugsNo Action Indicated (NAI)3013747223
Jul 27, 2018Blue Bell, PADrugsNo Action Indicated (NAI)3003494567
Oct 27, 2017Raleigh, NCDrugsNo Action Indicated (NAI)3013747223
Dec 21, 2016Blue Bell, PADrugsNo Action Indicated (NAI)3003494567
May 15, 2015Blue Bell, PADrugsNo Action Indicated (NAI)3003494567
May 6, 2014Lenexa, KSDrugsVoluntary Action Indicated (VAI)3007467677
Feb 10, 2014Blue Bell, PADrugsNo Action Indicated (NAI)3003494567

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 3003494567Blue Bell, PA16May 22, 2026
FEI 3038011239Assen, Netherlands1Oct 24, 2025
FEI 3016465959Dublin, Ireland2Jul 2, 2025
FEI 3013747223Raleigh, NC4Feb 28, 2025
FEI 3007467677Lenexa, KS2Nov 4, 2022
FEI 3008356812Marlow, United Kingdom1Jul 30, 2010

FDA data resources

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