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CryoLife Reviewing Tissue Sterilization Process In Wake Of Warning Letter

This article was originally published in The Gray Sheet

Executive Summary

FDA is increasing its scrutiny over validation of tissue processing practices, as evidenced by a June 17 warning letter to CryoLife

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CryoLife

Class action lawsuit filed July 8 in Georgia federal court by Little Rock law firm of Cauley, Geller, Bowman & Coates, LLP on behalf of shareholders who bought CryoLife stock between Aug. 11, 2000 and June 26, 2002 alleges the firm misled investors by purporting compliance with FDA regulations. CryoLife received a warning letter from FDA June 17 citing a number of validation deficiencies at its Kennesaw, Georgia facility (1"The Gray Sheet" July 1, 2002, p. 10)...

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