SOCRA CCRP Practice Exam

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Which document is crucial for a facility to respond to within a specified timeframe to avoid further action from the FDA?

  1. A Warning Letter

  2. An establishment inspection report

  3. A notice of compliance

  4. A certificate of approval

The correct answer is: A Warning Letter

A Warning Letter is the important document that a facility must respond to within a specified timeframe to avoid further action from the FDA. B, C, and D are incorrect because - An establishment inspection report (B) is a summary of findings from an FDA inspection, and it is important for a facility to address any issues raised in the report, but it is not the crucial document that imposes a deadline for response. - A notice of compliance (C) is a document that is issued by the FDA when a facility is in compliance with regulations, and it is not a request for action from the facility. - A certificate of approval (D) is a document that is issued by the FDA for certain products that are approved for marketing, and it is not relevant to responding to the agency's requests for corrective actions.

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