Companies shipping products to the United States may find their shipments subject to "Detention Without Physical Examination" by U.S. FDA. Products subject to detention without physical examination are held at the port of entry while U.S. FDA performs additional scrutiny, testing, and analysis. Delays from detention without physical examination may be lengthy for businesses anxious to deliver products on schedule.
U.S. FDA maintains "red lists" of companies or products subject to detention without physical examination. A company or product may be placed on a "red list" because of its own history of violations; U.S. FDA's assessment of the health risks by that company's products; because of factors beyond the company's control, such as a history of violations in the industry, country or region; or because of other health or sanitary risks, whether naturally occurring pests or within human control. It is not uncommon for a company to be placed on detention without physical examination without a single violative shipment.
U.S. FDA has procedures by which a company may be removed from a detention without physical examination "red list" and placed on a "green list" or "yellow list." To obtain removal, a firm must present sufficient evidence, appropriate to the circumstances of the particular detention without physical examination, to assure U.S. FDA that the company's products do not present the risk associated with the detention without physical examination. A history of non-violative shipments must be documented.
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