Hampton, Virginia (PRWEB) July 31, 2014
The U.S. () continues to refuse an increasing number of imports due to non-registered drug and medical device manufacturers and unlisted or unapproved drugs.[1]
requires foreign drug and medical device manufacturers to register with the FDA before exporting products to the United States. At the time of registration, foreign facilities must identify a U.S. agent and list all drugs or devices intended for use in the United States.
"Section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires firms that manufacture, prepare, propagate, compound, or process drugs in the U.S. or that are offered for import into the U.S. to register with the FDA. These domestic or foreign firms must at the time of registration, list all drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution in the U.S. Foreign establishments must identify a U.S. agent at the time of their registration."
"It's clear to us that FDA is increasing enforcement on these types of products," said Registrar Corp Vice President David Lennarz. "It is prudent for companies to make sure they comply before starting or continuing to export to the United States."
continue to read here
The U.S. () continues to refuse an increasing number of imports due to non-registered drug and medical device manufacturers and unlisted or unapproved drugs.[1]
requires foreign drug and medical device manufacturers to register with the FDA before exporting products to the United States. At the time of registration, foreign facilities must identify a U.S. agent and list all drugs or devices intended for use in the United States.
"Section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires firms that manufacture, prepare, propagate, compound, or process drugs in the U.S. or that are offered for import into the U.S. to register with the FDA. These domestic or foreign firms must at the time of registration, list all drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution in the U.S. Foreign establishments must identify a U.S. agent at the time of their registration."
"It's clear to us that FDA is increasing enforcement on these types of products," said Registrar Corp Vice President David Lennarz. "It is prudent for companies to make sure they comply before starting or continuing to export to the United States."
continue to read here
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