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The Warning Letter includes a statement that warns that failure to promptly correct the matter may result in an FDA enforcement action without further notice. It may include examples of such actions, but makes no commitment that the FDA will take these actions. [3]
Many commercial contracts include clauses that set out a process whereby notice must be given and in what form. Consequently, if there is a written contract, care should be taken to check the contract terms and to ensure compliance notwithstanding that the other party may, on the face of it, have committed a clear and repudiatory breach.
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.
The regulator issued warning letters to ByHeart Inc, Reckitt Benckiser Group's Mead Johnson Nutrition and Perrigo's Wisconsin unit. The FDA pulled up these companies for failing to establish ...
In law, a default is the failure to do something required by law or to comply with a contractual obligation.Legal obligations can arise when a response or appearance is required in legal proceedings, after taking out a loan, or as agreed in a contract; failure to carry them out puts one in defaults of the obligations.
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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 contract award can be challenged and set aside if a protester can prove that either the contracting agency or the contract awardee did not comply with the requirements of the solicitation. A successful protest can result in reconsideration of the decision to award the contract or award of the contract to the protester in lieu of the original ...
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