Tuesday, 7 January 2014

FDA Import Alert / Import refusal / Import detension

FDA Import Alert -
 Refusing Entry without Examination

FDA uses a number of enforcement measures to ensure the safety and quality of the products it regulates. Not only does it scrutinize new product applications for approval or clearance, but it continues to monitor products on the market. For instance, FDA conducts regular inspections of manufacturing facilities to ensure compliance with current Good Manufac­turing Practices (cGMPs), and conducts post marketing surveillance.

The Food, Drug, and Cosmetic Act authorizes FDA to detain a regulated product that appears to be out of compliance with the Act.FDA has the power to refuse admission of a product if, upon “examination of such samples or otherwise,” the product appears to have violated FD&C Act in one of four ways: the product was “manufactured, processed, or packed under insanitary conditions;” is forbidden or restricted in sale in the country in which it was produced or from which it was exported;” is adulterated or misbranded; or is in violation of certain recordkeeping requirements.

 An import alert allows FDA to detain, without physically exam­ining; products that either have or potentially could violate the Food, Drug, and Cosmetic Act.

Keeping unsafe foods, drugs, devices and other products from reaching consumers is the Food and Drug Administration’s mission. The preventive measures used by FDA is the issuance of import alerts to keep potentially dangerous products from other countries out of the U.S. marketplace.

Once a shipment is refused admission to the U.S., the importer has an opportunity to introduce evidence, within 10 days, to overcome the appearance of a violation. During this time, the product is either held at a warehouse or at the importer’s premises and cannot be distributed. If the shipment is not proven to be safe, it must be destroyed or exported within 90 days. The import alert will stay in place and all future shipments of the product will be denied admission until the violation is remedied, the importer provides enough evidence that the shipment is safe for consumers, or other conditions imposed by FDA are met.

An import alert can taint a business’s goodwill in the international market, and not only with respect to the product against which the alert is issued. A business’s entire line of products may be affected. In most circumstances, firms and products that are listed on the FDA’s import alert are automatically detained by the FDA without the added step of an inspection, examination, or sampling.

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