FDA Inspection
Dexta CorporationDexta Corporation – FDA Inspection, Mar 6, 2014
Record Details
This FDA Inspection record concerns Dexta Corporation, with an inspection on March 6, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Dexta Corporation
- Inspection Date
- March 6, 2014
- Product Type
- Devices
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ID · 54d0be4a-af99-4187-8e0c-8050522d8591
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 869842
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
16- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate 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 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
Showing 10 of 16 citations.
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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 |
| May 26, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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