FDA Audit Clears Blood Bank of Alaska of Allegations

Anchorage, AK – The Food and Drug Administration (FDA) began its annual audit process of Blood Bank of Alaska (BBA) on March 6, 2017.  A team offda-approved-logo two inspectors arrived unannounced and conducted the audit at the Airport Heights headquarters.  Every year Blood Bank of Alaska is audited by the FDA to ensure compliance with FDA regulations and guidelines.  The inspectors evaluated all systems involved with the blood collection, manufacturing, and distribution process. In addition to the standard areas of inspection the FDA also investigated the allegations brought against BBA in a report filed with the FDA by BBA employees (past and present). The audit process was completed on March 14, 2017.  The inspection and investigation resulted in no Form 483 being issued and it was determined that there was no validity to the allegations made. The FDA issues a Form 483 when an observed condition constitutes a violation of the Code of Federal Regulations.

Blood Bank of Alaska stated in previous statements that the allegations were unfounded.  As an FDA regulated organization it is BBA’s top priority to observe all guidelines and ensure donor safety.

“Blood Bank of Alaska is dedicated to the communities we serve and our partner hospitals. It is our responsibility to ensure that our donors are safe and feel safe when they donate the gift of life.  We are very proud of the work that our staff do every day and work to provide patients throughout Alaska with blood in their time of need,” Bob, Scanlon, CEO BBA.

BBA conducted an internal investigation in the Fall of 2016 prior the FDA audit to determine the validity of the allegations.  During this process the board of directors found no areas of concern.

“We welcome these results.  Last year, after the complaint was made to the FDA, the Board conducted an intensive investigation of each and every accusation within the larger complaint.  The results of the investigation showed overwhelmingly that the accusations were unfounded.  The FDA is the highest law in the land for blood banks and now they have independently confirmed the results of the internal investigation.  We knew all along that this would be the case but it’s nice to now have their results finalized,” Ryan York, BBA Board Chairman in 2016.

“This is an exceptional result that everyone associated with the Blood Bank should be proud of.  It reflects the professionalism and the hard work of staff at all levels of the organization, it reassures Alaskan donors that their donations are being handled appropriately, and, most importantly, it reassures Alaskan patients that any blood that they receive is coming from a facility that is fully compliant with all of the FDA’s standards,” stated Dr. Ian van Tets, Board Chairman BBA.