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An FDA Warning Letter is an official message from the United States Food and Drug Administration (FDA) that it has found that a manufacturer or other organization has violated some rule in a regulated activity. The FDA defines a Warning Letter as:
While the FDA generally determines violations through its own inspections, they can also issue one based on evidence from state personnel〔(''FDA'': Regulatory Procedures Manual, "4-3 - USE OF STATE EVIDENCE FOR FDA WARNING LETTERS AND UNTITLED LETTERS" ) Accessed 06 July 2010.〕 The FDA considers a Warning Letter informal and advisory. It communicates the agency's position on a matter, but does not commit the FDA to an enforcement action. For that reason, the FDA does not consider a Warning Letters a final action on which it can be sued.〔(''FDA'': Regulatory Procedures Manual, "4-1 - WARNING LETTERS". ) Accessed 06 July 2010.〕 The FDA expects most individuals, firms, and government establishments to voluntarily comply with the law. When the FDA observes a deviation from acceptable practice, they give the organization an opportunity to take voluntary and prompt corrective action before it initiates an enforcement action. A step in this process, depending on the nature of the violation, is to issue a Warning Letter, which also establishes ''prior notice.''〔 The agency has a computer application called the Compliance Management System (CMS, or MARC-CMS).) that district offices use to electronically submit Warning Letter recommendations to FDA Centers. All district office must use the CMS to submit the Warning Letter recommendation, the Form FDA 483 that supports the alleged violations, the Establishment Inspection Report (EIR), and any written response from the firm.〔 ==Warning Letter content== The elements listed below are common to Warning Letters:〔 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「FDA Warning Letter」の詳細全文を読む スポンサード リンク
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