CryoLife
This article was originally published in The Gray Sheet
Executive Summary
Tissue processing firm's interim agreement with FDA permitting continued distribution of its non-valved cardiac and vascular tissues is extended to June 13, CryoLife announces March 19. The agreement previously was set to expire March 20 (1"The Gray Sheet" Feb. 3, 2003, p. 22). CryoLife is preparing its response to FDA concerns stemming from a recent inspection, outlined in a 483 report, which largely relate to complaint handling, according to the company (2"The Gray Sheet" March 10, 2003, p. 29)...
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