This webinar provides attendees with an introduction to FDA Import Alerts and what they are, examine why they are issued, show you where to locate them and how to determine whether a company or product is on one, and finally, provide strategic recommendations for removal from an alert.
Import Alerts can cause serious problems for a company including business disruptions, delayed distribution, contract breaches and financial losses. It can also present serious issues for downstream customers and contractors especially when orders are not being filled and product is not being delivered.
FDA maintains lists of Import Alerts naming companies or products that fail to comply with its regulations or that it suspects of being noncompliant. There does not need to be an actual showing of noncompliance but simply a belief that a product poses a safety risk.
The Federal Food, Drug, and Cosmetic Act and its regulations allow FDA to detain, without physical examination, products that either violate or potentially violate the law. Such products are added to an Import Alerts to notify FDA staff and the general public that the Agency has enough evidence or other information to refuse admission of future shipments from coming into the United States. Some of the factors influencing whether a company or product is added to an Import Alert include the product or manufacturer itself, geographical area, ingredients, labeling and/or country of origin.
When listed on an Import Alert, FDA field staff and customs agents are directed to detain all shipments of the particular product or all products from the company. Inspection of the product(s) is no longer needed to detain the product. Detention is now automatic.
A company or product will remain on an Import Alert until evidence or other information is provided to FDA giving it confidence that the problem has been resolved, the product in question is safe for consumers and that all future shipments will be in compliance with the law. The conditions for removal vary depending on the requirements of the particular Import Alert.
Once a company or its products are removed from an Import Alert, the company may resume shipping product into the United States without fear of automatic detention. At this point it is now business as usual again.
Learning objectives:
Karl M. NoberPresident, ReCellerate, Inc.
Karl Nobert, Esq. is an FDA Regulatory Attorney with the law firm of Michael Best in their Washington, DC office.
Karl focuses his practice in FDA Regulatory law, representing U.S. and international clients in the food and drug industries with regard to pharmaceuticals and OTC drugs, biologics, medical devices, food and beverages including dairy products, cosmetics vitamins and dietary supplements; and veterinary products. He has particular experience in the areas of prescription drugs and regenerative medicine, and has counseled numerous clients seeking FDA approval for Rx drugs and cellular-based products to treat both humans and animals.
Karl has significant experience in the areas of understanding FDA product detentions and developing strategic solutions for the removal of companies and products from Import Alerts. He has successfully assisted multiple clients with resolving costly detention issues including a large Canadian food company with multi-national operations, several Japanese drug and ingredient manufacturers, a European beverage maker, an Israel-based pharmaceutical distributor and a start-up pet product company.
An Import Alert allows FDA to detain, without physical examination, products that may violate the Food, Drug, and Cosmetic Act and FDA’s regulations. Import Alerts make FDA staffers and the general public aware that the Agency has sufficient evidence or suspicions about the safety of a product to refuse admission of future shipments of the product. Once a manufacturer or product is added to the list all future imports will be prohibited until the issue is resolved.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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