What is a field alert report?

A field alert report is a crucial communication tool used within the pharmaceutical industry to ensure safety and regulation compliance. It specifically involves the submission of information to the FDA concerning any potential defects related to drug products that could affect their safety, efficacy, or quality. This report is typically triggered by findings such as contamination, packaging defects, or significant deviations from established product specifications. The timely submission of a field alert report allows regulatory agencies to take necessary action to mitigate risks to public health, which is essential in maintaining the integrity of the pharmaceutical supply chain and safeguarding patient safety.

The other options do not align with the definition of a field alert report; they pertain to different types of reports or notifications relevant to public health and consumer safety.