Momenta Pharmaceuticals, Inc. (MNTA)

[jbog]

Randy,

You are given ample time to resolve most problems well prior to receiving a warning letter.

When something is flagged upon inspection you have a opportunity to resolve it right then and there. You will have a re-examination months later to confirm it has been delt with.

Once you get the inspectors report listing the deficiencies, if it wasn't addressed originally you get months to reply to the FDA with your proposed solution and timeframe.

If this isn't satisfactory to the FDA, or upon re-examination, or upon finding falsified documentation, or upon finding that you're not living up to your CGMP policy you'll then receive a FDA warning letter.

This could easily be 18 months or so from finding the original infraction.