Warning Letters

<p>When it is consistent with the public protection responsibilities of the agency and depending on the nature of the violation, it is the Food and Drug Administration's (FDA's) practice to give individuals and firms an opportunity to take voluntary and prompt corrective action before it initiates an enforcement action. Warning Letters are issued to achieve voluntary compliance and to establish prior notice. The use of Warning Letters and the prior notice policy are based on the expectation that most individuals and firms will voluntarily comply with the law. See <a href="http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm176870.htm">http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/uc...</a> for additional infomation on Warning Letters.</p>

当符合该机构对公众保护责任时，根据违规行为的性质，食品药品监督管理局（FDA）的惯例是在采取执法行动之前，给予个人和公司自愿且迅速采取纠正措施的机会。警告信的发出旨在实现自愿遵守并设立事先通知。警告信的使用及事先通知政策基于大多数个人和公司会自愿遵守法律的预期。有关警告信的更多信息，请参阅<a href="http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm176870.htm">http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/uc...</a>。