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Izun Pharmaceuticals Corporation

FDA Regulatory Profile

Izun Pharmaceuticals Corporation has 0 FDA recalls, 2 inspections, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
Apr 11, 2022 · NAI
Latest 510(k)
Mar 3, 2017

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances2Oct 4, 2026Not statedCurrent
Inspections2Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Apr 11, 2022New York, NYDevicesNo Action Indicated (NAI)3008510523
Nov 29, 2017New York, NYDevicesVoluntary Action Indicated (VAI)3008510523

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.

Recent 510(k) Clearances

K-NumberDeviceDate
K161991CurasiteMar 3, 2017
K103054PERIOPATCHFeb 7, 2011

FDA data resources