FDA Inspection
VE Valley Electronics GmbHVE Valley Electronics GmbH – FDA Inspection, Oct 18, 2012
Record Details
This FDA Inspection record concerns VE Valley Electronics GmbH, with an inspection on October 18, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- VE Valley Electronics GmbH
- Inspection Date
- October 18, 2012
- Product Type
- Devices
View Company Profile
ID · 1f022514-90dd-4292-9457-0e82d8e756fc
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 806462
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 820.30(g)Design validation acceptance criteria
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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.