FDA Inspection
Daniels Sharpsmart IncDaniels Sharpsmart Inc – FDA Inspection, Dec 1, 2011
Record Details
This FDA Inspection record concerns Daniels Sharpsmart Inc, with an inspection on December 1, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Daniels Sharpsmart Inc
- Inspection Date
- December 1, 2011
- Product Type
- Devices
View Company Profile
ID · 844265d5-108d-453c-83e6-d4e201d40afb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 755237
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.70(f)Buildings
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
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Other FDA inspections of Daniels Sharpsmart Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 11, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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