What happens if I am a Covered Facility and fail to register, update required information or cancel my registration in accordance with the FDAs regulations?
Failure to comply with the regulations is a prohibited act under the Federal Food, Drug, and Cosmetic Act. The Federal government can bring a civil action to ask a Federal court to enjoin (prevent) persons who commit a prohibited act from continuing import activities, or it can bring a criminal action in Federal court to prosecute persons who are responsible for the commission of a prohibited act. If a Covered Facility is required to register but fails to do so, food from that foreign facility that is offered for import into the U.S. is subject to being held at the port of entry unless otherwise directed by FDA or the Bureau of Customs and Border Protection (CBP). The FDA will publish the Compliance Policy Guide concerning the agency’s policies regarding refusals of imported food under section 801(m)(1) or holds of imported food under section 801(l). This guide will be available through Zephyr Partner’s website when published.
Related Questions
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