Becton Dickinson says 'cooperating fully with FDA'
BD issued the following statement in response to receiving a warning letter from the U.S. FDA for its Preanalytical Systems business unit. Richard Byrd, worldwide president of BD Preanalytical Systems said: "Ensuring the safety and quality of our products is our top priority at BD, and we are dedicated to maintaining a robust quality system to fulfill this commitment. We take any potential issue with our products very seriously and are cooperating fully with FDA on this matter. After the FDA inspection in July, we took prompt action that we believed fully addressed the agency's inspectional observations. We are carefully reviewing the agency's feedback outlined in yesterday's letter with the highest sense of urgency, and we will provide a full response to FDA on or before their Feb. 1 deadline. We will continue to demonstrate our commitment to serving the public health as well as meeting FDA's expectations."