A warning letter is an administrative action typically issued to firms with a [[Situation I]] condition identified on their [[FDA 483]] observations. Warning letters require a written repsonse from the firm within 15 working days.

Warning letters are normally received within 30 days of the firm's receipt of the from [[FDA 483]] observations.
bag
fda_public
created
Sun, 24 Jun 2012 14:32:10 GMT
creator
dirkjan
modified
Sun, 24 Jun 2012 14:32:10 GMT
modifier
dirkjan
tags
FDA
Term
creator
dirkjan