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The agency has a computer application called the Compliance Management System (CMS, or MARC-CMS) that district offices use to electronically submit warning letter recommendations to FDA Centers. All district office must use the CMS to submit the warning letter recommendation, the Form FDA 483 that supports the alleged violations, the ...
The header identifies the FDA district office that performed the inspection, the date(s) of inspection, name and address of the facility that was inspected, the name and title of the individual to whom the 483 is issued to (usually the most responsible individual physically present in the facility), a brief description of the type of facility, and the facility's FEI (FDA Establishment ...
Malicious compliance (also known as malicious obedience) is the behavior of strictly following the orders of a superior despite knowing that compliance with the orders will have an unintended or negative result. It usually implies following an order in such a way that ignores or otherwise undermines the order's intent, but follows it to the letter.
A no-action letter is a letter written by the staff members of a government agency, requested by an entity subject to regulation by that agency, indicating that the staff will not recommend that the agency take legal action against the entity, should the entity engage in a course of action proposed by the entity through its request for a no-action letter.
Compliance requirements are only guidelines for compliance with the hundreds of laws and regulations applicable to the specific type assistance used by the recipient, and their objectives are generic in nature due to the large number of federal programs. [1] Each compliance requirement is identified by a letter, in alphabetical order.
In United States pharmaceutical regulatory practice, a Complete Response Letter (CRL), or more rarely, a 314.110 letter, is a regulatory action by the Food and Drug Administration in response to a New Drug Application, Amended New Drug Application or Biologics License Application, indicating that the application will not be approved in its present form. [1]