What are the U.S. Food and Drug Administrations required provisions for issuing Certificates?
A. FDA will issue Certificates assuming the product meets the requirements of 801(e) of the Federal Food, Drug, and Cosmetics Act as follows: • accords to the specifications of the foreign purchaser, • is not in conflict with the laws of the country to which it is intended for export, • is labeled on the outside of the shipping package that is intended for export, and • the particular shipment is not sold or offered for sale in domestic commerce. Q. What should I include when requesting a Certificate? A. Each request should be accompanied by: • an original label or, if no labels have been printed, a detailed draft version of the current label, • sufficient information for each product for which a certificate is requested so the reviewer can properly identify the product • adequate identification of the actual manufacturer of each product • the following statement: “The requester hereby presents and acknowledges that the company is aware that in making this request the company is subjec
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