FDA 483 - OneBlood, Inc. - April 02, 2019

OneBlood, Inc. in Fort Lauderdale, FL, a blood establishment computer software manufacturer, received eight observations during an FDA inspection. The firm was cited for significant deficiencies across its quality system, including inadequate design controls, corrective and preventive actions, medical device reporting, and complaint handling. These issues led to problems such as unresolved duplicate donor records, software failures, and untimely reporting of adverse events.