FDA Inspection
ET Medical Devices S.p.A.ET Medical Devices S.p.A. – FDA Inspection, Feb 3, 2011
Record Details
This FDA Inspection record concerns ET Medical Devices S.p.A., with an inspection on February 3, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ET Medical Devices S.p.A.
- Inspection Date
- February 3, 2011
- Product Type
- Devices
View Company Profile
ID · 85ec11ab-3e43-493f-b68b-17e321c503b5
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 710023
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
11- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
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