FDA 483 - LifeSouth Community Blood Centers, Inc

An FDA inspection of LIFESouth Community Blood Center, a cord blood processor in Gainesville, Florida, revealed significant deficiencies across its quality system. Observations included failures to report major product label changes, lack of ongoing stability data for cord blood units, and an inadequate change control program. The firm also lacked proper contractual agreements with service providers, had deficient Standard Operating Procedures, and exhibited insufficient employee training in critical operations.