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/default.htm
o Under “Recalls and Alerts”, click on “Warning Letters”
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Order Paper Nowo 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?
