Updating: FDA Warning Letter - Material Omissions??
I will reserve judgement till the issues are addressed. I find it interesting that this inquiry by the FDA is targeted to certain specifics as if it were DD by a competitior in the field drawing into question if this procedure truely does fall within the guidelines or not. I mean it would be of interest as to at whose behest these points were decided to be focal points of the inspection. As it reads item for item along the lines of exactly what an opposing party would draw up as bullet points for a presentation of why another company should be inspected. Especially if that other companies processes stood to suffer potentially severe damage from a quicker less costly and equally or better effective same procedure. I have had some experience with inspections and usually if the resources are available a company simply goes about directing its procedures to meet those guidelines. If the cost savings and effectiveness are there, then no matter what stipulations are made, once met, the outcome will be a shift to the better procedure. Maybe this was a standard inspection however I just find it odd for an FDA inspector to make this sort of finding without being some kind of expert in the field or at the least make the finding a collaboration of experts. It would be easy for competition to take these assertions to the FDA and go about using their supposed expertise raise the questions. Guess we will see how Victor and company respond.