ENG 4

 Medical Device QSR Violations – Can expand to 1.5 pages to accommodate QMP actions; 750 words

1. Go to: http://www.fda.gov/default.htm

2. Find “Recalls and Alerts” tab. Click on “Warning Letters”

3. Under “Ways to browse warning letters”, click on “Browse Warning Letters by Issuing Office”.

4. Click on “Center for Devices and Radiological Health”

5. Find and click on warning letter for A C Cossor & Son.

Summarize the specific violations of Quality System Regulations listed from 1-8 and 14.