FDA Inspection
MedXpert GmbHMedXpert GmbH – FDA Inspection, Jan 21, 2014
Record Details
This FDA Inspection record concerns MedXpert GmbH, with an inspection on January 21, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- MedXpert GmbH
- Inspection Date
- January 21, 2014
- Product Type
- Devices
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ID · d904d345-9540-4445-98e1-5dd93963af0a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 865687
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - 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
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