FDA Inspection
US Endoscopy Group IncUS Endoscopy Group Inc – FDA Inspection, Jul 21, 2011
Record Details
This FDA Inspection record concerns US Endoscopy Group Inc, with an inspection on July 21, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- US Endoscopy Group Inc
- Inspection Date
- July 21, 2011
- Product Type
- Devices
View Company Profile
ID · 6801b95a-d1e4-4917-88b3-eba2913fc323
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 736932
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
Full citation text and observation details available on the Dashboard.
Other FDA inspections of US Endoscopy Group Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 7, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 14, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for US Endoscopy Group Inc
- FDA Inspection 994835 - 2016-12-07
- FDA Inspection 799141 - 2012-09-14
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