Replies to post #239925 on Biotech Values

[DewDiligence]

[Items] 3, 4, & 5 all seem to be quality control items. Are those likely to require another inspection?

I don't know—good question.

[jbog]

3, 4, & 5 all seem to be quality control items. Are those likely to require another inspection?

In most cases there will be a re-inspection because of the hard items noted.

The 483 is handed over to management at the end of the inspection and the inspectors clearly spell out their findings. An inspector doesn't have any authority to impose anything,



His report and a establishment report is consider for approval.

The inspector has nothing to do regarding a CRL, that's a decision made by the FDA. If there was a 'hard' date that the FDA had to meet for a decision there would have no choice but to issue a CRL. There is no date that I'm aware of.