Source: FDA, document on file. FDA released the Form 483 itself. The document linked above is our copy of FDA's file, stored by us so the link cannot break, and FDA's own copy is linked beside it. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3001451326.
Observations7
Issue DateJuly 11, 2015
StatusNo Warning Letter
Establishment TypeHuman Tissue and Medical Device Manufacturer
Related Inspections10
Establishment Details
Firm
Artivion, Inc
Issued To
CryoLife, Inc.
Location
Kennesaw, Georgia, United States
FEI Number
3001451326
Establishment Type
Human Tissue and Medical Device Manufacturer
Product Type
Devices
Issue Date
July 11, 2015
Country
United States
Inspection History, 2010 to 2026
NAI6
VAI2
OAI2
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
Talk to a Specialist