FDA Inspection
Biodex Medical Systems, Inc.Biodex Medical Systems, Inc. – FDA Inspection, May 1, 2018
Record Details
This FDA Inspection record concerns Biodex Medical Systems, Inc., with an inspection on May 1, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e9b3f509-64f6-4ebe-aff7-d14337c40a94
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1050414
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.80(b)Incoming acceptance records, documentation
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 1002.30(a)(1)Quality control procedures
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Other FDA inspections of Biodex Medical Systems, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| February 10, 2023 | 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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