U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. CryoLife, Inc. - 04/23/2015
  1. Warning Letters


CryoLife, Inc.

CryoLife, Inc.

United States

Issuing Office:

United States


Department of Health and Human Services' logoDepartment of Health and Human Services

Food and Drug Administration
 Atlanta District Office
60 Eighth Street N.E.
Atlanta, GA 30309

Telephone: 404-253-1161 


April 23, 2015

James P. Mackin
CEO & President
Cryolife, Inc.
1655 Roberts Blvd NW
Kennesaw, GA 30144

Dear Mr. Mackin:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, 13-ATL-07, dated January 29, 2013. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.



Ingrid Zambrana
District Director
Atlanta District Director

Back to Top