New Data on the Inspection of Human Cell & Tissue Products by the FDA

A recent report charting inspectional information by the FDA for human cell/tissue therapeutic products shows a marked increase in inspection activity.
The period covered is 2003-2010 and reports an increase in the number of inspections by about 250%, with an average duration of each inspection of 40-45 hours.
During that period, voluntary compliance actions taken by companies as a result of inspections has increased 255% and official action taken has increased 240%. This is against a background of a 260% rise in inspections where no action was indicated.
Interestingly, the most significant increase has occurred between 2009-2010 where there was a 57% jump in inspection activity of these companies by the FDA.
One assumes this is occurring as a result of the exploding interest in cell & tissue therapeutic products and concerns about their relative safety?

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