Company
MalaysiaPlexus Manufacturing Sdn. Bhd., Bayan Lepas, Malaysia – FDA Inspections
Inspection records and compliance data for Plexus Manufacturing Sdn. Bhd. in Bayan Lepas. 7 FDA inspections on record, last inspected November 20, 2025.
Company Profile
This profile covers Plexus Manufacturing Sdn. Bhd. based in Bayan Lepas, Malaysia.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 3
- NAI
- 4
- Form 483s
- 0
- Warning letters
- 0
First inspected January 14, 2009. Last inspected November 20, 2025.
Most cited issue areas
- Analysis of data/reports from data sources1 inspection
- Documentation1 inspection
- Nonconforming product, Lack of or inadequate procedures1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 20, 2025 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1293036 |
| June 8, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1209397 |
| November 16, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 993647 |
| May 8, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 882455 |
| May 24, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 789454 |
| May 7, 2010 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 662818 |
| January 14, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 567261 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Plexus Manufacturing Sdn. Bhd.
FEI Number
3004593495
Address
Bayan Lepas Free Industrial Zone, Phase Ii, Bayan Lepas, Malaysia
Country
Malaysia
ID: 03e34fc3-660c-4ef5-b909-999f9b6bee4d