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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. [1]
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.
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.
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 ...
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.
In the North American legal system and in US Occupational Safety and Health Administration regulations, willful violation or willful non-compliance is a violation of workplace rules and policies that occurs either deliberately or as a result of neglect.
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A demand letter, letter of demand, [1] (of payment), or letter before claim, [2] is a letter stating a legal claim (usually drafted by a lawyer) which makes a demand for restitution or performance of some obligation, owing to the recipients' alleged breach of contract, or for a legal wrong.