FDA Inspection
Plexus Manufacturing Sdn. Bhd.Plexus Manufacturing Sdn. Bhd. – FDA Inspection, Nov 11, 2022
Record Details
This FDA Inspection record concerns Plexus Manufacturing Sdn. Bhd., with an inspection on November 11, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 11, 2022
- Product Type
- Devices
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ID · 43fcd402-5759-417a-9d65-2dc8c03eb24a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1191695
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.184DHR content
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Plexus Manufacturing Sdn. Bhd.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| September 6, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Plexus Manufacturing Sdn. Bhd.
- FDA Inspection 1066211 - 2018-08-09
- FDA Inspection 1016078 - 2017-05-04
- FDA Inspection 956722 - 2015-12-10
- FDA Inspection 906477 - 2014-10-16
- FDA Inspection 848678 - 2013-09-06
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