FDA Inspection
Biodex Medical Systems, Inc.Biodex Medical Systems, Inc. – FDA Inspection, Feb 10, 2023
Record Details
This FDA Inspection record concerns Biodex Medical Systems, Inc., with an inspection on February 10, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ad242f78-c5ef-4cf8-88b6-0dff4d2c3bab
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1199302
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.40(b)Document change records, maintained.
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Other FDA inspections of Biodex Medical Systems, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 1, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 17, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 20, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 4, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 22, 2011 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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