FDA Inspection
Medibo N.V.Medibo N.V. – FDA Inspection, Jan 22, 2009
Record Details
This FDA Inspection record concerns Medibo N.V., with an inspection on January 22, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Medibo N.V.
- Inspection Date
- January 22, 2009
- Product Type
- Devices
View Company Profile
ID · 4d4440ed-5b70-439c-b4eb-71520ca79e65
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 563389
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(a)Complete files maintained
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.198(d)Records of MDR Investigation
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.30(g)Design validation - simulated testing
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