FDA Inspection
Direx Systems Corp.Direx Systems Corp. – FDA Inspection, Oct 8, 2014
Record Details
This FDA Inspection record concerns Direx Systems Corp., with an inspection on October 8, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Direx Systems Corp.
- Inspection Date
- October 8, 2014
- Product Type
- Devices
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ID · 99bd4d3e-fe7a-4ca9-a8e5-f874d4edc178
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 899351
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
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Other FDA inspections of Direx Systems Corp.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 12, 2017 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| April 4, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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