FDA Inspection
Plexus Manufacturing Sdn. Bhd.Plexus Manufacturing Sdn. Bhd. – FDA Inspection, Sep 6, 2013
Record Details
This FDA Inspection record concerns Plexus Manufacturing Sdn. Bhd., with an inspection on September 6, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 6, 2013
- Product Type
- Devices
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ID · 90838f8e-beae-48f5-9054-0967991e79d7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 848678
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Plexus Manufacturing Sdn. Bhd.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 11, 2022 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| August 9, 2018 | Not classified | Office of Inspections and Investigations | |
| May 4, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 10, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 16, 2014 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Plexus Manufacturing Sdn. Bhd.
- FDA Inspection 1191695 - 2022-11-11
- FDA Inspection 1066211 - 2018-08-09
- FDA Inspection 1016078 - 2017-05-04
- FDA Inspection 956722 - 2015-12-10
- FDA Inspection 906477 - 2014-10-16
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