FDA Inspection
3CPM Company., INC.- EndoSure, Inc.3CPM Company., INC.- EndoSure, Inc. – FDA Inspection, Feb 25, 2011
Record Details
This FDA Inspection record concerns 3CPM Company., INC.- EndoSure, Inc., with an inspection on February 25, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 25, 2011
- Product Type
- Devices
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ID · 2a76c481-6a09-4fc2-ab50-96d4bfcb5c9a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 709696
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 820.40(b)Change records, content
- 21 CFR 820.30(g)Design validation - software validation documentation
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Other FDA inspections of 3CPM Company., INC.- EndoSure, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 22, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 6, 2009 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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