SOCRA CCRP Practice Exam

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What is a Warning Letter from the FDA intended to prompt?

Immediate shutdown of operations
Voluntary corrective action within a specified time
Immediate payment of fines
Start of legal proceedings

The correct answer is: Voluntary corrective action within a specified time

A Warning Letter from the FDA is not intended to cause immediate shutdown of operations (option A) or immediate payment of fines (option C). It is a serious, formal notice from the FDA to a company identifying violations of regulatory significance, and it is intended to prompt the company to take voluntary corrective action within a specified time (option B). As such, it is not necessarily the start of legal proceedings (option D), but rather is meant to prevent potential legal action by addressing and correcting the identified issues.