FDA Inspection
Daniels Sharpsmart IncDaniels Sharpsmart Inc – FDA Inspection, Dec 11, 2009
Record Details
This FDA Inspection record concerns Daniels Sharpsmart Inc, with an inspection on December 11, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Daniels Sharpsmart Inc
- Inspection Date
- December 11, 2009
- Product Type
- Devices
View Company Profile
ID · 86e63813-705c-4dff-ac15-0a64bd5ccb0f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 634655
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.150(a)Storage procedures to prevent mix-ups
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 820.100(b)Procedures
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Other FDA inspections of Daniels Sharpsmart Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 1, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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