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The Warning Letter requests corrections and a written response within a specific period after receipt of the letter—usually fifteen working days. The district, at its discretion, may offer the recipient an opportunity to discuss the letter with district officials or, when appropriate, with center officials.
Form FDA 483. The U.S. Food and Drug Administration (FDA) is authorized to perform inspections under the Federal Food, Drug, and Cosmetic Act, Sec. 704 (21 USC §374) "Factory Inspection". [1] Form FDA 483, [2] "Inspectional Observations", is a form used by the FDA to document and communicate concerns discovered during these inspections.
Tobacco package warning messages are warning messages that appear on the packaging of cigarettes and other tobacco products concerning their health effects. They have been implemented in an effort to enhance the public's awareness of the harmful effects of smoking. In general, warnings used in different countries try to emphasize the same messages.
Specific Area Message Encoding (SAME) is a protocol used for framing and classification of broadcasting emergency warning messages. It was developed by the United States National Weather Service for use on its NOAA Weather Radio (NWR) network, and was later adopted by the Federal Communications Commission for the Emergency Alert System, then subsequently by Environment Canada for use on its ...
Long-term nuclear waste warning messages. Long-term nuclear waste warning messages are communication attempts intended to deter human intrusion at nuclear waste repositories in the far future, within or above the order of magnitude of 10,000 years. Nuclear semiotics is an interdisciplinary field of research, first established by the American ...
Complete Response Letter. In United States pharmaceutical regulatory practice, a Complete Response Letter (CRL), or more rarely, a 314.110 letter, is a regulatory action by the Food and Drug Administration in response to a New Drug Application, Amended New Drug Application or Biologics License Application, indicating that the application will ...
warning. In United States law, the Garrity warning is a notification of rights usually administered by federal, state, or local investigators to their employees who may be the subject of an internal investigation. The Garrity warning advises subjects of their criminal and administrative liability for any statements they may make, but also ...
Making false statements (18 U.S.C. § 1001) is the common name for the United States federal process crime laid out in Section 1001 of Title 18 of the United States Code, which generally prohibits knowingly and willfully making false or fraudulent statements, or concealing information, in "any matter within the jurisdiction" of the federal government of the United States, [1] even by merely ...
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