is this why fda delays are getting longer?, page-8

A possible reason for the 3 month delay?

Try FDA now very worried about the systemic reasons for Dr Reddy's poor management of safety at its Indian plants and high level FDA staff have asked for all the ANDA documentation and are now taking a closer look at it all.

Whatever the field of certification, inspection/audit reports always have minor non-compliances. These aren't normally show stoppers and they are expected to be fixed by the time of the next inspection. Given DRL's recent fatality history, and if I were the head of ANDAs at the FDA, they are the sorts of things I'd now be taking a closer look at before putting my signature on an approval. The question has to be "do they walk the talk" with respect to compliance systems.