483
OneBlood, Inc.FDA 483 - OneBlood, Inc. - April 08, 2019
Record Details
OneBlood, Inc. in Marianna, FL was inspected on April 8, 2019, and cited for a significant lapse in quality assurance. The firm failed to perform a thorough investigation and adequately document the conclusions and follow-up for an unexplained discrepancy involving a donor who experienced anemia after a donation. This indicates deficiencies in their corrective and preventive action (CAPA) processes and record-keeping.
View Company Profile
ID · e3c725dc-64b1-4811-82a1-3e0c0be170da
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.