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Isomedix Operations, Inc.

FDA Regulatory Profile

Isomedix Operations, Inc. has 0 FDA recalls, 108 inspections, 2 510(k) clearances and 2 compliance actions on record.

Latest inspection
Aug 27, 2026 · NAI
Latest 510(k)
Nov 4, 1997

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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) clearances2Nov 8, 2026File dated Nov 2, 2026Current
Inspections108Nov 10, 2026Newest record Nov 5, 2026Current
Compliance actions2Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 27, 2026El Paso, TXBiologicsNo Action Indicated (NAI)1643817
Apr 3, 2026San Diego, CADevicesNo Action Indicated (NAI)3003076831
Mar 12, 2026Spartanburg, SCDevicesNo Action Indicated (NAI)1047843
Jan 27, 2026Libertyville, ILBiologicsVoluntary Action Indicated (VAI)3003015552
Sep 17, 2025Libertyville, ILDrugsNo Action Indicated (NAI)1450662
Aug 1, 2025Northborough, MABiologicsNo Action Indicated (NAI)1220477
Jun 18, 2025Temecula, CADevicesNo Action Indicated (NAI)3000206435
Jun 17, 2025Groveport, OHDevicesNo Action Indicated (NAI)1526711
Jun 5, 2025Grand Prairie, TXDevicesNo Action Indicated (NAI)3002681132
May 15, 2025Sandy, UTBiologicsNo Action Indicated (NAI)1720929
May 8, 2025Whippany, NJDrugsNo Action Indicated (NAI)2245304
Feb 21, 2025Chester, NYDevicesNo Action Indicated (NAI)3013820501
Dec 12, 2024Chester, NYDevicesVoluntary Action Indicated (VAI)1000136478
Dec 11, 2024Ontario, CABiologicsNo Action Indicated (NAI)3003058448
Sep 23, 2024Libertyville, ILDevicesNo Action Indicated (NAI)3003015552
Sep 19, 2024Libertyville, ILDevicesNo Action Indicated (NAI)1450662
Aug 29, 2024Whippany, NJBiologicsNo Action Indicated (NAI)2245304
Jun 6, 2024Chester, NYDrugsNo Action Indicated (NAI)1000136478
Dec 13, 2023Spartanburg, SCDevicesNo Action Indicated (NAI)1047843
Sep 18, 2023Libertyville, ILDrugsVoluntary Action Indicated (VAI)3003015552

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 1643817El Paso, TX4Aug 27, 2026
FEI 3003076831San Diego, CA4Apr 3, 2026
FEI 1047843Spartanburg, SC8Mar 12, 2026
FEI 3003015552Libertyville, IL9Jan 27, 2026
FEI 1450662Libertyville, IL11Sep 17, 2025
FEI 1220477Northborough, MA10Aug 1, 2025
FEI 3000206435Temecula, CA6Jun 18, 2025
FEI 1526711Groveport, OH6Jun 17, 2025
FEI 3002681132Grand Prairie, TX4Jun 5, 2025
FEI 1720929Sandy, UT7May 15, 2025
FEI 2245304Whippany, NJ12May 8, 2025
FEI 3013820501Chester, NY3Feb 21, 2025
FEI 1000136478Chester, NY8Dec 12, 2024
FEI 3003058448Ontario, CA7Dec 11, 2024
FEI 2183744Coon Rapids, MN6Sep 15, 2023
FEI 2246552South Plainfield, NJ3Mar 1, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K970352SMARTVAC SMOKE EVACUATION SYSTEMNov 4, 1997
K950047SCHNEIDER GEX(TM) .014/.018 GUIDEWIRE EXCHANGE CATHETERApr 5, 1995

FDA data resources

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