FDA Inspection
Rhein83 S.r.l.Rhein83 S.r.l. – FDA Inspection, Jun 17, 2010
Record Details
This FDA Inspection record concerns Rhein83 S.r.l., with an inspection on June 17, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Rhein83 S.r.l.
- Inspection Date
- June 17, 2010
- Product Type
- Devices
View Company Profile
ID · 68bfb957-da04-4aae-8283-1bb011c6a505
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 668193
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.80(e)Documentation
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.120(b)Examination for accuracy
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(j)Design history file
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