RE:RE:RE:RE:RE:RE:So here is someting to talk aboutYa you are right, they will just go to Walmart and ask them to verify it. Come on Rock, I am sure SONA already has this covered and ready to go once validation comes in. You like to copy an paste stuff from articles without really thinking that a company that has come this far will not have this in their back pocket.
IV. Conditions of Authorization
M. You must have lot release procedures and the lot release procedures, including the study design and statistical power, must ensure that the tests released for distribution have the clinical and analytical performance claimed in the authorized labeling.
N. If requested by FDA, you must submit lot release procedures to FDA, including sampling protocols, testing protocols, and acceptance criteria, that you use to release lots of your product for distribution in the U.S. If such lot release procedures are requested by FDA, you must provide it within 48 hours of the request.
Definitely need to hire some industial engineers can not contract eveyrhing with strict deadlines.