FDA 483 - American Red Cross Biomedical Services Headquarters - July 03, 2008

The FDA Form 483 details multiple violations at American Red Cross Biomedical Services, observed between December 2006 and April 2008 across four ARC Blood Service Regions. The primary issue is a pervasive failure to control non-conforming and potentially non-conforming blood products, leading to their distribution and subsequent retrieval.

Specifically, ARC logged approximately 116 exception reports in "Smart" involving distributed non-conforming blood products, resulting in 218 retrievals. Additionally, 29 exception reports related to donor suitability (health history/Blood Donation Record deviations) led to 43 retrievals. Six ABO/Rh discrepancies and one HLA discrepancy resulted in five retrievals. Two whole blood number discrepancies led to nine retrievals. Three potential air contamination issues during collection resulted in 12 retrievals. Six incomplete/unreviewed Apheresis Procedure Records led to nine retrievals. Seven instances of incomplete product testing or unreviewed validation records resulted in 22 retrievals. In all these cases, products were not controlled prior to distribution.

Furthermore, ARC failed to submit approximately 10 biological product deviation reports (BPDRs) within the required 45 days, as mandated by Paragraph X.D. of the April 15, 2003 Consent Decree of Permanent Injunction, for approximately 27 distributed non-conforming blood products. Examples include donor suitability deviations discovered in April and July 20