| http://www.w3.org/ns/prov#value | - FDCA]. (2) The Regulatory Procedures Manual makes clear that warning letters are informal and advisory and that they do[] not commit FDA to taking enforcement action. (3) Indeed, FDA discounts such letters as a basis upon which it can be sued. (4) Unlike formal FDA advisory opinions, FDA warning letters are merely the judgment of particular agency employees and do[] not necessarily represent
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