Global Health Solutions, LLC

FDA Regulatory Profile

Global Health Solutions, LLC has 0 FDA recalls, 3 inspections, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
Oct 27, 2022 · NAI
Latest 510(k)
Aug 25, 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
Inspections3Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Oct 27, 2022Westlake Village, CADevicesNo Action Indicated (NAI)3012147657
Jul 3, 2019Westlake Village, CADevicesVoluntary Action Indicated (VAI)3012147657
Aug 14, 2017Westlake Village, CADrugsVoluntary Action Indicated (VAI)3012147657

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
K171191Hexagen DermAug 25, 2017
K160872PolyPlex Wound DressingNov 23, 2016