SOCRA CCRP Practice Exam

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How must a facility respond to a Warning Letter from the FDA?

Provide an explanation within a year
Ignore until a second notice
Respond promptly within a specified amount of time
Request a dismissal of the letter

The correct answer is: Respond promptly within a specified amount of time

A Providing an explanation within a year is not an appropriate response to a Warning Letter from the FDA as it requires a prompt and timely response. B: Ignoring the letter until a second notice is not a suitable response as it could result in further action from the FDA, leading to potential consequences for the facility. D: Requesting a dismissal of the letter is not a recommended response as it does not address the issues raised by the FDA and may be seen as evasive or non-compliant. It is important for the facility to respond to the letter promptly and address any concerns raised by the FDA. Therefore, option C is the correct response as it demonstrates a proactive and compliant approach to the Warning Letter.