FDA Inspection
Dexta CorporationDexta Corporation – FDA Inspection, May 26, 2010
Record Details
This FDA Inspection record concerns Dexta Corporation, with an inspection on May 26, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Dexta Corporation
- Inspection Date
- May 26, 2010
- Product Type
- Devices
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ID · ed5c4c55-6d57-4780-888e-eb7f29678a56
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 663287
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Dexta Corporation
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 3, 2015 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 6, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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