FDA Inspection
US Endoscopy Group IncUS Endoscopy Group Inc – FDA Inspection, Dec 7, 2016
Record Details
This FDA Inspection record concerns US Endoscopy Group Inc, with an inspection on December 7, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 9605cbe1-1030-49c0-b2c9-2a54c597c954
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 994835
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
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Other FDA inspections of US Endoscopy Group Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 14, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 21, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for US Endoscopy Group Inc
- FDA Inspection 799141 - 2012-09-14
- FDA Inspection 736932 - 2011-07-21
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