Plexus Manufacturing Sdn. Bhd.

FDA Regulatory Profile

Plexus Manufacturing Sdn. Bhd. has 0 FDA recalls, 12 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Nov 20, 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
Inspections12Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Nov 20, 2025Bayan Lepas, MalaysiaDevicesNo Action Indicated (NAI)3004593495
Jun 8, 2023Bayan Lepas, MalaysiaDevicesNo Action Indicated (NAI)3004593495
Nov 11, 2022Bayan Lepas, MalaysiaDevicesVoluntary Action Indicated (VAI)3006786907
May 4, 2017Bayan Lepas, MalaysiaDevicesNo Action Indicated (NAI)3006786907
Nov 16, 2016Bayan Lepas, MalaysiaDevicesNo Action Indicated (NAI)3004593495
Dec 10, 2015Bayan Lepas, MalaysiaDevicesNo Action Indicated (NAI)3006786907
Oct 16, 2014Bayan Lepas, MalaysiaDevicesVoluntary Action Indicated (VAI)3006786907
May 8, 2014Bayan Lepas, MalaysiaDevicesVoluntary Action Indicated (VAI)3004593495
Sep 6, 2013Bayan Lepas, MalaysiaDevicesVoluntary Action Indicated (VAI)3006786907
May 24, 2012Bayan Lepas, MalaysiaDevicesNo Action Indicated (NAI)3004593495
May 7, 2010Bayan Lepas, MalaysiaDevicesVoluntary Action Indicated (VAI)3004593495
Jan 14, 2009Bayan Lepas, MalaysiaDevicesNo Action Indicated (NAI)3004593495

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 3004593495Bayan Lepas, Malaysia7Nov 20, 2025
FEI 3006786907Bayan Lepas, Malaysia5Nov 11, 2022

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