CryoLife, Inc. - Oct. 16, 2012
Issue Date
Oct 16, 2012
Region
Southeast
Category
Device
$117.00
Address 1
1655 Roberts Blvd. Nw
City
Kennesaw
State
GA
Zip/Postal Code
30144-3632
Country
US
Inspection Range
Sep 17, 2012 - Oct 16, 2012
Pages
16
First Observation
Process validation activities and results have not been adequately documented.
Investigator(s): Claudette D. Brooks, Trang N. Cox, Kimberly C. Delk-Brooks, Leslie W. Gilbert, Tammara A. Stephens, and Melanie M. Walker