I have two questions. In the warning letters the FDA sends out with the findings, does the Company not have a responsibility to correct those findings in a reasonable time, just like we in automotive with CA's. Why does it say no date given? And why are there still companies operating, that have received findings last year or the year before? Does the finding determine the date?
My other question is, seeing that the particular companies ISO cert is expiring October 2011, I am wondering if they had their re-cert audit already with the same CB and were re-certified even under the current circumstances. Anyone know?