FDA Inspection
Plexus Manufacturing Sdn. Bhd.Plexus Manufacturing Sdn. Bhd. – FDA Inspection, May 7, 2010
Record Details
This FDA Inspection record concerns Plexus Manufacturing Sdn. Bhd., with an inspection on May 7, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 7, 2010
- Product Type
- Devices
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ID · ce62c5dd-a3ac-47c1-8fb2-522818711042
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 662818
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 820.100(a)(1)Analysis of data/reports from data sources
- 21 CFR 820.90(a)Specific non-conforming product procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.100(b)Procedures
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Other FDA inspections of Plexus Manufacturing Sdn. Bhd.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| November 20, 2025 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 8, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 16, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 8, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 24, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Plexus Manufacturing Sdn. Bhd.
- FDA Inspection 1293036 - 2025-11-20
- FDA Inspection 1209397 - 2023-06-08
- FDA Inspection 993647 - 2016-11-16
- FDA Inspection 882455 - 2014-05-08
- FDA Inspection 789454 - 2012-05-24
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