When a product is identified as illegitimate or high risk suspect for illegitimacy, what action must the manufacturer take and within what time frame?

• A. Notify the FDA within 24 hours.
• B. Notify the FDA within 7 days.
• C. Quarantine the product and wait for instructions.
• D. Document the issue for internal records only.

Answer: (A)

Timely reporting to the FDA is the essential requirement. Once a product is identified as illegitimate or a high-risk suspect for illegitimacy, the manufacturer must notify the FDA within 24 hours of becoming aware of the issue. This rapid notification enables swift regulatory action, traceability, and potential recalls to protect patients and the integrity of the supply chain. Quarantining the product and awaiting instructions, or treating the matter as something to document only internally, do not meet the regulatory mandate for prompt FDA alert. A delay beyond 24 hours (such as 7 days) undermines safety and regulatory oversight, whereas immediate FDA notification within 24 hours is the correct, required action.