Media Statement Regarding Fines Assessed by the Food and Drug Administration
(NewDesignWorld Press Center) - The American Red Cross issued the following statement regarding the fines assessed by the Food and Drug Administration:
The American Red Cross and the Food and Drug Administration (FDA) both are seeking to ensure the safest possible blood products are provided when needed by recipients.
While the FDA fines cover a number of facilities, they are primarily centered on an inspection conducted 15 months ago at our Donor & Client Support Center (DCSC) in Philadelphia. We are disappointed that the FDA believed it necessary to issue a fine for an inspection conducted so long ago and it is important to know we have already taken corrective steps to address those matters and that improvements in operations have been made. We are not aware of any adverse donor reactions or patient issues due to the problems in the FDA report.
The Red Cross is fully committed to meeting all FDA standards, has made significant progress in working with the FDA to comply with their regulations and requirements, and continues to work on improving its performance.
The Red Cross consolidated its blood donor management from more than 30 facilities into two Donor and Client Support Centers. We were aware of some of the challenges from this consolidation in mid-2010 and were already taking action in many areas. Additional issues were cited by investigators during the FDA inspection in October, 2010, and the Red Cross initiated corrective steps to address those matters as well.
The blood supply is safer today than ever before, and people should not hesitate to give or receive blood. Giving blood helps save lives, and we appreciate all those who help others in need by giving blood.
Discuss Bury
NDW PR Center is a Web 2.0 News release and distribution service
