FDA Inspection
Mediagnost GmbHMediagnost GmbH – FDA Inspection, Jan 11, 2012
Record Details
This FDA Inspection record concerns Mediagnost GmbH, with an inspection on January 11, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Mediagnost GmbH
- Inspection Date
- January 11, 2012
- Product Type
- Devices
View Company Profile
ID · c69b2be7-0be3-4583-93b4-fc071d076a5b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 762942
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.184DHR content
- 21 CFR 820.70(g)Equipment Installation, Placement, Specified Requirements
- 21 CFR 803.17Lack of Written MDR Procedures
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