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

Question

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).

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

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”?

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

Explanation / Answer

As from first paragraph it has been notified that the inspections are conducted as part of FDA's Bioresearch Monitoring Program which includes inspections designed to verify compliance with Title 21 of the Code of Federal Regulations (cfr) part 58 of the Good Laboratory Pratice Regulationds.

SNBL Testing Facility Management Has the primary reponsibilityto establish appropriate policies and procedures intended to ensure the quality and integrity of nonclinical safety data for FDA submission.

Within 15 business days SNBL are supposed to respond to the FDA issues after receiving the Warning letter.

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