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  2. FDA warning letter - Wikipedia

    en.wikipedia.org/wiki/FDA_Warning_Letter

    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 ...

  3. Wikipedia:Standard license violation letter - Wikipedia

    en.wikipedia.org/wiki/Wikipedia:Standard_license...

    Prior to sending out one of these letter please read the Non-compliance process guideline at Wikipedia's Mirrors and forks. A general consensus supports this process. [1] [2] Note: These letters are intended for material that is dually licensed under CC-BY-SA and GFDL, as most of Wikipedia's articles are (since June 15, 2009).

  4. Form FDA 483 - Wikipedia

    en.wikipedia.org/wiki/Form_FDA_483

    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 ...

  5. Type approval - Wikipedia

    en.wikipedia.org/wiki/Type_approval

    Type approval or certificate of conformity is granted to a product that meets a minimum set of regulatory, technical and safety requirements. Generally, type approval is required before a product is allowed to be sold in a particular country, so the requirements for a given product will vary around the world.

  6. Complete Response Letter - Wikipedia

    en.wikipedia.org/wiki/Complete_Response_Letter

    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]

  7. Brady disclosure - Wikipedia

    en.wikipedia.org/wiki/Brady_disclosure

    In order to ensure compliance with Brady, the United States Supreme Court repeatedly urged the "careful prosecutor" to favor disclosure over concealment. [16] Conformity with Brady is a continuing obligation of prosecutors. Some prosecuting attorney offices have adopted and created specialized procedure and bureaus to meet their burden. [17 ...

  8. Letter of comfort (contract law) - Wikipedia

    en.wikipedia.org/wiki/Letter_of_comfort...

    A letter of comfort, sometimes called a "letter of intent", is a communication from a party to a contract to the other party that indicates an initial willingness to enter into a contractual obligation absent the elements of a legally enforceable contract. The objective is to create a morally binding but not legally binding assurance.

  9. Malicious compliance - Wikipedia

    en.wikipedia.org/wiki/Malicious_compliance

    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.

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