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When does FDA refuse to issue an Export Certificate?
FDA will not issue a Certificate to Foreign Government or a Certificate of a Pharmaceutical Product for products that do not meet the applicable requirements of the Act. Additionally, such certificates will not be issued if FDA has initiated an enforcement action (e.g., a seizure or an injunction). Other examples of circumstances for which certificates will not be issued include: Failure of the manufacturing facility(ies) to operate in compliance with the cGMP regulations (unless the particular exported product is not affected by the specific cGMP deficiencies); Manufacturing facility(ies) not registered or listed with FDA; and When the product is not exported from the United States. FDA will not issue Certificates of Exportability for products subject to section 802 of the Act if the manufacturing facility(ies) does not comply with cGMP regulations, unless the particular exported product is not affected by the specific cGMP deficiencies. FDA also will not issue Certificates of Free Sale and Health Certificates for Food/Feed when products are under FDA regulatory action (e.g., the product is under seizure or the firm is under injunction).
U.S. Food and Drug Administration (FDA)
http://www.fda.gov
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