Company
MalaysiaPlexus Manufacturing Sdn. Bhd., Bayan Lepas, Malaysia – FDA Inspections
Inspection records and compliance data for Plexus Manufacturing Sdn. Bhd. in Bayan Lepas. 6 FDA inspections on record, last inspected November 11, 2022.
Company Profile
This profile covers Plexus Manufacturing Sdn. Bhd. based in Bayan Lepas, Malaysia.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 3
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected September 6, 2013. Last inspected November 11, 2022.
Most cited issue areas
- DHR content2 inspections
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 11, 2022 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1191695 |
| August 9, 2018 | Not classified | Medical Devices & Rad Health | 1066211 |
| May 4, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1016078 |
| December 10, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 956722 |
| October 16, 2014 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 906477 |
| September 6, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 848678 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Plexus Manufacturing Sdn. Bhd.
FEI Number
3006786907
Address
Plot 87, 88 & 89 Lebuhraya Kampung Jawa, Bayan Lepas, Malaysia
Country
Malaysia
ID: 9fecff52-6fa5-4e2e-af29-ad9aa0232f89