FDA Inspection
Health Robotics SrlHealth Robotics Srl – FDA Inspection, Nov 12, 2010
Record Details
This FDA Inspection record concerns Health Robotics Srl, with an inspection on November 12, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Health Robotics Srl
- Inspection Date
- November 12, 2010
- Product Type
- Devices
View Company Profile
ID · a2b6b781-338a-411f-ac7b-07a885bbc276
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 700232
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design validation - software validation documentation
- 21 CFR 820.30(g)Design validation - documentation
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