What action should the Canadian regulatory professional recommend after a serious incident involving a product sold only in the US?

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The correct recommendation in the scenario presented is to report the incident to the Health Products and Food Branch Inspectorate (HPFBI). This action is crucial because even though the product is sold only in the United States, regulatory professionals in Canada have an obligation to ensure safety and compliance with health regulations. Reporting serious incidents helps to maintain oversight of products that could potentially impact Canadian health and safety, ensuring that any related issues are addressed appropriately.

Reporting to the HPFBI can help identify trends or safety concerns that may transcend borders, allowing for prompt responses that protect consumers. The HPFBI plays a vital role in monitoring and responding to incidents related to health products, thus supporting public health initiatives.

In contrast, filing the incident in the complaints data, reporting it to the company's president, or taking no action at all would not fulfill the ethical and regulatory responsibilities towards consumer safety and could lead to larger issues if the concerns are not communicated to the appropriate regulatory authorities. It is essential for regulatory professionals to act within the framework of safety regulations, even for products that are not directly marketed in Canada.

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