CryoLife, Inc., a leading medical device and tissue processing company focused on cardiac and vascular surgery, announced today that it has received a close-out letter from the United States Food and Drug Administration ("FDA") verifying that the Company has successfully implemented corrective actions put in place following the warning letter it received from the FDA in January 2013.
The close-out letter follows a re-inspection in March 2015 by the FDA at CryoLife's manufacturing facility and headquarters in Kennesaw, GA. The receipt of the close-out letter confirms that all items in the warning letter were closed, with the FDA determining that the Company's remediation activities are effective and its quality management system is in substantial compliance. No FDA 483 observations were issued as part of the follow-up inspection.
Pat Mackin, Chairman, President, and Chief Executive Officer, said, "Resolving the FDA warning letter was my top priority when I joined the Company. I am pleased that we passed the recent FDA re-inspection with no 483 observations and that the FDA has lifted our warning letter. The CryoLife team did a great job responding to the FDA's concerns, and we are committed to the continued enhancement of our quality systems and delivery of the highest quality products to patients."
CryoLife, Inc., a leading medical device and tissue processing company focused on cardiac and vascular surgery, announced today the appointment of William Matthews to the newly created position of Senior Vice President, Operations, Quality, and Regulatory, effective May 1, 2015. Mr. Matthews will report directly to Pat Mackin, Chairman, President, and Chief Executive Officer.
Mr. Mackin commented, "Bill is a seasoned industry executive with over 30 years of experience, with 10 years spent at Fortune 500 Companies, including Fresenius and Cardinal Health groups, leading quality, regulatory, and operations functions. Bill's operational management, integration, new technology startup, and FDA experience, coupled with the knowledge of our business he obtained through a recent engagement with our Company, will help us execute on our growth initiatives while driving efficient and compliant manufacturing operations. We look forward to his contribution to CryoLife during this transformative time for the business."
Before joining CryoLife, Mr. Matthews was Managing Partner at BioDevice Solutions, a Medical device consultancy firm, where he served as an advisor and Senior Consultant to numerous medical device companies. Mr. Matthews is recognized for his extensive experience in FDA compliance matters, manufacturing operations, new technology startups, product approvals and clearances, as well as numerous successful domestic and international submissions. Prior to that, Mr. Matthews served as Vice President of Government Affairs and Quality Systems for Cardinal Health's Viasys Healthcare; Executive Vice President of Operations, Regulatory Affairs, and Quality Systems at Xylum Corporation, where he was responsible for the Company's product development, manufacturing, engineering and regulatory affairs; and the Corporate Director of Regulatory, Quality, Manufacturing, and Engineering at Fresenius Medical Care (formerly Grace National Medical Care division) where he was responsible for all domestic and international manufacturing facilities.
Mr. Matthews obtained a Bachelor's degree in Chemistry from St. Peter's University and also attended the Business Administration Programs at Rutgers University and Fairleigh Dickinson University.
Source: Metro Atlanta CEO, http://metroatlantaceo.com/news/2015/04/cryolife-announces-resolution-fda-appoints-william-matthews-svp/