Is anyone else disturbed by the recent Genzyme warning letter?
Is the FDA setting new precedents?
The firm seemed to be on track to meeting their 483 response commitments, so why did the FDA send them a warning letter?
It appears that the FDA seems to be questioning the integrity of product released while these commitments were being fulfilled. Does this mean that in the future a firm must stop all product and release activities until 483 response commitments are fully completed? The observations of concern appear to be centered around microbial control and monitoring issues and therefore must be the FDA's justification for these extraordinary measures. However, the warning letter did not indicate that there was any evidence of product adulteration. Where is the fire? I will need to read the EIR to try to get a better understanding of these events. After which, I will try to post my findings.
