FDA Inspection
Sunoptic Technologies, LLCSunoptic Technologies, LLC – FDA Inspection, Nov 22, 2010
Record Details
This FDA Inspection record concerns Sunoptic Technologies, LLC, with an inspection on November 22, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sunoptic Technologies, LLC
- Inspection Date
- November 22, 2010
- Product Type
- Devices
View Company Profile
ID · 8e39df27-4548-4c5b-aa92-403f268b66f1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 699549
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
9- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.72(b)Calibration procedures - content
- 21 CFR 820.40(b)Document changes, review and approval, communication
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.160(a)Lack of or inadequate procedures for distribution
- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
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Other FDA inspections of Sunoptic Technologies, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 7, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 14, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Sunoptic Technologies, LLC
- FDA Inspection 890011 - 2014-08-07
- FDA Inspection 730736 - 2011-06-14
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