483
OneBlood, Inc.FDA 483 - OneBlood, Inc. - June 06, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
An FDA inspection of OneBlood, Inc., a blood bank in St Petersburg, FL, revealed a significant and recurrent issue with regulatory compliance. The firm failed to submit 23 out of 282 biological product deviation reports within the mandated 45-day timeframe. This indicates an ongoing problem with timely reporting of critical events.
Open in Dashboard
ID · cfe8e453-52f6-4e9d-8b72-5c304711274f