FDA Inspection
Getemed Medizin-und Informationstechnik AGGetemed Medizin-und Informationstechnik AG – FDA Inspection, Jun 29, 2017
Record Details
This FDA Inspection record concerns Getemed Medizin-und Informationstechnik AG, with an inspection on June 29, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- June 29, 2017
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 8033f686-f736-484f-850b-c5868edc7c2c
Inspection Facts
- Inspection number
- 1016756
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.70(i)Software validation for automated processes
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