HW 7

Go to:

http://www.fda.gov/default.htm

o   Under “Recalls and Alerts”, click on “Warning Letters”

o   Under “Ways to View/Browse Warning Letters”, type GLP in the search box. Click on “Search”.

o   Examine the table showing the “Warning Letters Search Results”.  What are the different centers (3) in the FDA that that issue GLP warning letters?

Go to:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm222775.htm

Summarize and comment on specific GLP violations by SNBL in the warning letter (specific actions/activities or lack thereof). 

o   From the first paragraph, the inspections are conducted as part of which FDA program? 

o   Which personnel has “primary responsibility to establish appropriate policies and procedures intended to ensure the quality and integrity of nonclinical safety data for FDA submission”?

o   Within how many business days of the Warning Letter receipt is SNBL supposed to respond to the FDA issues?