Matches in DBpedia 2015-10 for { <http://dbpedia.org/resource/FDA_Warning_Letter> ?p ?o }
- FDA_Warning_Letter abstract "The United States Food and Drug Administration (FDA) defines a Warning Letter as "...a correspondence that notifies regulated industry about violations that FDA has documented during its inspections or investigations. Typically, a Warning Letter notifies a responsible individual or firm that the Agency considers one or more products, practices, processes, or other activities to be in violation of the Federal Food, Drug, and Cosmetic Act (the Act), its implementing regulations and other federal statutes. Warning Letters should only be issued for violations of regulatory significance, i.e., those that may actually lead to an enforcement action if the documented violations are not promptly and adequately corrected. A Warning Letter is one of the Agency’s principal means of achieving prompt voluntary compliance with the Act.While violations are generally determined through the FDA's own inspections, they can also be issued based upon evidence obtained by state personnel A Warning Letter is considered by the agency to be informal and advisory. While it communicates the agency's position on a matter it does not commit the FDA to taking enforcement action. For these reasons the FDA does not consider Warning Letters to be final actions on which it can be sued.The FDA expects that most individuals, firms, and government establishments will voluntarily comply with the law. When departures are observed the FDA gives an 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 serves to establish "prior notice."The agency has a computer application called the Compliance Management System (CMS, or MARC-CMS).) that is used for electronically submitting Warning Letter recommendations from district offices to FDA Centers. All recommendations by the district offices must use the CMS for submitting the proposed Warning Letter, the Form FDA 483 that supports the alleged violations, the Establishment Inspection Report (EIR), and any written response by the firm.".
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