FDA Inspection
CPR Medical Devices, Inc.CPR Medical Devices, Inc. – FDA Inspection, Jul 14, 2011
Record Details
This FDA Inspection record concerns CPR Medical Devices, Inc., with an inspection on July 14, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- CPR Medical Devices, Inc.
- Inspection Date
- July 14, 2011
- Product Type
- Devices
View Company Profile
ID · 58681a7d-0cf6-41d0-a3a9-a34fa8722a83
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 737690
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.50(b)Supplier notification of changes
Full citation text and observation details available on the Dashboard.
Other FDA inspections of CPR Medical Devices, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 17, 2008 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for CPR Medical Devices, Inc.
- FDA Inspection 553078 - 2008-12-17
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.