FDA 483 - The Blood Center - June 17, 2022

An FDA inspection of The Blood Center in New Orleans, LA, from June 13-17, 2022, revealed significant deficiencies in quality control and documentation practices. Observations included failures to thoroughly investigate temperature excursions of blood components, maintain adequate records, and adhere to standard operating procedures for storage and transfer. The firm also failed to submit a required biological product deviation report within the specified timeframe.