FDA Inspection
MEDDEV USA, INC.MEDDEV USA, INC. – FDA Inspection, May 11, 2012
Record Details
This FDA Inspection record concerns MEDDEV USA, INC., with an inspection on May 11, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- MEDDEV USA, INC.
- Inspection Date
- May 11, 2012
- Product Type
- Devices
View Company Profile
ID · 7b03b4d9-906e-40b9-83dc-877c3d2aaf31
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 780737
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
10- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.20(a)Quality policy and objectives
- 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.