HCT/P Compliance Update. 5th Annual FDA and the Changing Paradigm for HCT/P Regulation Las Vegas, NV, January 28, 2009 Mary Malarkey, Director, OCBQ, CBER. Summary. Inspections by the numbers Inspectional Observations Regulatory citations HCT/P cases HCT/P Deviation Reports Recalls.
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5th Annual FDA and the Changing Paradigm for HCT/P Regulation
Las Vegas, NV, January 28, 2009
Mary Malarkey, Director, OCBQ, CBER
*Sum of individual inspections do not equal total due to some inspections that were conducted for products in multiple categories
The DeMarco Case and Beyond
*From FDA News Release , December 19, 2007
*commonly called Lou Gehrig’s disease
By ANDREW POLLACK
Published: January 29, 2008
*- This table does not include 3 “mixed class” recalls
INNOVATIVE TECHNOLOGY ADVANCING PUBLIC HEALTH
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