| | | Good point, Doc. But they should keep the team and bring in the right fda consultants to get this done asap.
Problem is, shutdown might be an immovable object.
Btw, when they do an inspection, my experience with feds is they tell you specifics on the spot. The immu team that escorted them for a week long inspection has a very good idea what was wrong. They dont just write a cryptic note on the 483. Note that multiple immu personnel signed each page acknowleging the observations. Let' s get real. They know exactly what is wrong. They may not know exactly what it takes to get it right, but that is what the ex fda folks are supposed to tell them.
Honestly, everything on there is common sense. You test each level, keep the data fastidiously, keep track of ingredients, clean room data, etc. There is always a possibility that a final test is so complete that some of the earlier stuff can be overridden, but this is what a good system/process engineer can explain. They have to have people who know all this stuff, they couldnt have repeatedly made the product otherwise. Looks like they did not put the right people on the response team.
I really think the problem is that those extensive lab mods are still in process, and the fda probably needs to reinspect. If LRDCs observations are correct, they still are not done! |
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