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Polyganics Holding BV

FDA Regulatory Profile

Polyganics Holding BV has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Sep 4, 2025 · 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
Inspections4Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Sep 4, 2025Groningen, NetherlandsDevicesNo Action Indicated (NAI)3022140316
Nov 21, 2019Groningen, NetherlandsDevicesVoluntary Action Indicated (VAI)3004504732
Aug 6, 2015Groningen, NetherlandsDevicesVoluntary Action Indicated (VAI)3004504732
Jun 18, 2009Groningen, NetherlandsDevicesVoluntary Action Indicated (VAI)3004504732

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 3022140316Groningen, Netherlands1Sep 4, 2025
FEI 3004504732Groningen, Netherlands3Nov 21, 2019

FDA data resources

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