FDA 483 - American Red Cross Blood Services Great Lakes Region - March 21, 2008

The FDA Form 483 details observations from an inspection of a blood product facility, identifying multiple failures in quality control and regulatory compliance.

**Observation 1:** Failure to identify, investigate, and correct problems, and to control suspect or non-conforming blood products. * On January 16, 2008, a potential mix-up of donor sample test tubes occurred at the Great Lakes Region, involving whole blood units (b)(6) and (b)(6). * The Detroit National Testing Laboratory (NTL) discovered the discrepancy on January 16, 2008, and notified the Region. * Red blood cells (RBCs) from these units were distributed on January 22, 2008. * On January 17, 2008, the NTL informed the Region of receiving too many tubes, but the Region stated all samples were acceptable, and no exception report was opened until February 7, 2008. * An exception report (b)(4) was created by the NTL on January 23, 2008, for running samples with an incorrect number of tubes. * The NTL contacted the Region on January 29, 2008, to quarantine in-house products and opened a (b)(4) case for distributed product. * The exception