FDA 483 - LifeSouth Community Blood Centers, Inc - February 27, 2020

An FDA inspection of Life South Community Blood Centers, a cord blood manufacturer in Gainesville, Florida, revealed significant deficiencies in their quality system. Observations included incomplete investigations for failed stability testing and a failure to report biological product deviations. Additionally, the firm lacked written procedures for quality control unit responsibilities, such as resolving ABO blood typing discrepancies and managing cord blood unit disposition, and did not assess all deviations as part of its Annual Product Review.