Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure to adequately address this matter may lead to regulatory action. If you believe that your drug product is not in violation of the FD&C Act, please include in your submission to us your reasoning and any supporting information for our consideration within 15 working days from the date of receipt of this letter. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will do so.