An<unk>  is an official message from the United States Food and Drug Administration <unk>  to a manufacturer or other organization that has violated some rule in a federally regulated activity. The<unk>  defines an<unk>  as: ... a correspondence that notifies regulated industry about violations that<unk>  has documented during its inspections or investigations. Typically, a<unk><unk>  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.<unk><unk> s 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<unk><unk>  is one of the Agency's principal means of achieving prompt voluntary compliance with the Act. While the<unk>  generally determines violations through its own inspections, they can also issue one based on evidence from state personnel. The<unk>  considers a<unk><unk>  informal and advisory. It communicates the agency's position on a matter, but does not commit the<unk>  to an enforcement action. For that reason, the<unk>  does not consider a<unk><unk>  a final action on which it can be sued. The<unk>  expects most individuals, firms, and government establishments to voluntarily comply with the law. When the<unk>  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<unk><unk> , 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<unk><unk>  recommendations to<unk>  Centers. All district office must use the CMS to submit the<unk><unk>  recommendation, the Form<unk>  483 that supports the alleged violations, the Establishment Inspection Report (EIR), and any written response from the firm.
FDA warning letter
FDA citizen petition
Incident report
Death certificate
Drug coupon
Medication package insert
Boxed warning
Drug labelling