FDA Inspection
Mevis Medical Solutions AGMevis Medical Solutions AG – FDA Inspection, Jun 24, 2015
Record Details
This FDA Inspection record concerns Mevis Medical Solutions AG, with an inspection on June 24, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Mevis Medical Solutions AG
- Inspection Date
- June 24, 2015
- Product Type
- Devices
View Company Profile
ID · 5c1bfdd6-217d-4dbd-a37e-8f1212b02e08
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 934613
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 820.80(e)Documentation
- 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 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.30(e)Design review - documentation
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.