FDA's practice, depending upon the nature of a violation of regulations, is 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. Warning Letters are issued only for violations of regulatory significance. Significant violations may lead to enforcement action if not promptly and adequately corrected. A Warning Letter is the agency's principal means of achieving voluntary compliance with applicable laws and regulations. | 
