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imnot6

03/02/17 3:46 PM

#16925 RE: mouton29 #16924

IMO, "may" in the letter's context simply means "have the right/authority to" and not much else.

As opposed to "are obligated to" for example, because some law or established rule mandates a particular consequence.

With the new administration, it may morph to something like "we may or may not - we'll leave you in suspense.."
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jbog

03/02/17 4:24 PM

#16926 RE: mouton29 #16924

has the FDA ever in fact, approved a product produced in a facility receiving a warning letter.



As of my knowledge the answer is no. But this punishment or policy, which ever way we view it, is relatively new.

In my view people are dreaming if they feel the FDA would skirt this policy.

You have a better chance hoping that the FDA may change their policy.