对于那些如果不能及时充分地纠正可能会导致强制措施的违规情况，FDA会签发警告信。
FDA USES Warning Letters for violations that may lead to enforcement action if they are not promptly and adequately corrected.
与警告信不同，当发现的偏差不立即改正不会对患者健康造成直接危害时，FDA就会签发无标题函。
Unlike a Warning Letter, an Untitled Letter is issued by the FDA when there is no immediate danger for patients' health if the deviations observed are not corrected immediately.
这时FDA就会签发一封警告信或无标题信函，具体发何种信函则取决于违规行为的性质。
FDA will issue either a Warning Letter or an Untitled Letter, depending upon the nature of the violation.
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