Plexus Manufacturing Sdn. Bhd.
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
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 12 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Nov 20, 2025 | Bayan Lepas, Malaysia | Devices | No Action Indicated (NAI) | 3004593495 |
| Jun 8, 2023 | Bayan Lepas, Malaysia | Devices | No Action Indicated (NAI) | 3004593495 |
| Nov 11, 2022 | Bayan Lepas, Malaysia | Devices | Voluntary Action Indicated (VAI) | 3006786907 |
| May 4, 2017 | Bayan Lepas, Malaysia | Devices | No Action Indicated (NAI) | 3006786907 |
| Nov 16, 2016 | Bayan Lepas, Malaysia | Devices | No Action Indicated (NAI) | 3004593495 |
| Dec 10, 2015 | Bayan Lepas, Malaysia | Devices | No Action Indicated (NAI) | 3006786907 |
| Oct 16, 2014 | Bayan Lepas, Malaysia | Devices | Voluntary Action Indicated (VAI) | 3006786907 |
| May 8, 2014 | Bayan Lepas, Malaysia | Devices | Voluntary Action Indicated (VAI) | 3004593495 |
| Sep 6, 2013 | Bayan Lepas, Malaysia | Devices | Voluntary Action Indicated (VAI) | 3006786907 |
| May 24, 2012 | Bayan Lepas, Malaysia | Devices | No Action Indicated (NAI) | 3004593495 |
| May 7, 2010 | Bayan Lepas, Malaysia | Devices | Voluntary Action Indicated (VAI) | 3004593495 |
| Jan 14, 2009 | Bayan Lepas, Malaysia | Devices | No Action Indicated (NAI) | 3004593495 |
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3004593495 | Bayan Lepas, Malaysia | 7 | Nov 20, 2025 |
| FEI 3006786907 | Bayan Lepas, Malaysia | 5 | Nov 11, 2022 |