FDA Import Alerts
FDA Import Alerts, also called FDA automatic detention lists, are used by FDA to provide notice to its District Offices and FDA import inspection and compliance officers that a foreign manufacturer and its products appear to be in violation of the Food Drug and Cosmetic Act (FDCA) or FDA regulations. In most circumstances, firms and products that are listed on an FDA Import Alert are automatically detained by FDA without the added step of FDA conducting an inspection, examination or sampling of the product. FDA automatically detains products on FDA Import Alert without physical examination (also called Detention Without Physical Examination or DWPE).
A foreign manufacturer that finds its products are listed on an FDA Import Alert is facing a challenge to import its products into the U.S. However, Environmental Testing Laboratory Inc. (ETL), regularly assists foreign manufacturers in obtaining removal or exemption from FDA Import Alerts or automatic detention lists. Firms listed on an FDA Import Alert will find it harder to compete in the U.S. marketplace. The FDA publishes its Import Alerts on the Internet, so competitors and potential customers are able to see that a firm has been added to an FDA Import Alert and its products are subject to automatic detention (or DWPE). It is very important for manufacturers or shippers listed on an FDA import alert to get off of the alert as soon as possible.
FDA Import Alerts instruct FDA import inspectors, investigators, and compliance officers to automatically detain or detain without physical examination all imports of the affected products from the listed manufacturer, shipper, grower, or geographic area. Once on an Import Alert, FDA will continue to automatically detain the affected products until the manufacturer, shipper, grower, or importer demonstrates to FDA that the violation has been corrected.
There are different types of FDA Import Alerts, including those Import Alerts that identify a specific manufacturer, shipper, grower, and product combination. Some Import Alerts list specific geographic areas that have presented problems for FDA. Depending upon the problem and the kind of evidence FDA has regarding imported products, the geographic region affected could be an entire country (called a country wide import alert, such as applies to Chinese aquaculture seafood products or black pepper from India) or even worldwide (effectively creating an automatic barrier to all international trade in that commodity). Examples of worldwide FDA Import Alerts include tamarind products or products containing tamarind as an ingredient, and fresh seafood in vacuum or modified atmosphere packaging. For country wide or worldwide FDA import alerts, manufacturers can be exempted from automatic detention if they provide details to FDA in a written petition demonstrating the import alert does not properly apply to them.
Environmental Testing Laboratory Inc., represents many foreign food, drug, cosmetic, and medical device companies before FDA seeking and obtaining removal or exemption from FDA Import Alerts of all types and covering all kinds of commodities and industries. If you find your imported foods, drugs, cosmetics or medical devices are subject to FDA automatic detention because of an FDA Import Alert, contact ETL and let us show you The Way Through to the U.S. market again.
Being listed on an FDA Import Alert could be devastating to a foreign company, which may not even be aware it is on the alert. For instance, an importer may have obtained the manufacturer's product from a third country or from a shipper who was not authorized to ship to the U.S. In such cases, the manufacturer may learn it is on the alert only after it ships to an authorized distributor in the U.S. and finds FDA automatically detaining legitimate shipments because the agency previously caught unauthorized shippers exporting products never intended for the U.S. market and out of compliance with U.S. laws.
There are over 150 separate FDA Import Alerts that affect, literally, thousands of manufacturers, shippers, growers and importers, and hundreds of countries. Dont be one of them. Let ETL seek removal or exemption of your firm from FDA Import Alert, making The Way Through clear for your imported food, cosmetic, drug, or medical device.
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