FDA Inspection
Dexta CorporationDexta Corporation – FDA Inspection, Feb 3, 2015
Record Details
This FDA Inspection record concerns Dexta Corporation, with an inspection on February 3, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Dexta Corporation
- Inspection Date
- February 3, 2015
- Product Type
- Devices
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ID · cb514bbd-c4d9-4875-b5cb-3787919f442f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 910140
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Dexta Corporation
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 6, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 26, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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