483
American Red Cross Blood ServFDA 483 - American Red Cross Blood Serv - August 15, 2019
Record Details
The FDA inspected American Red Cross Blood Serv in Rochester, NY, from August 13-15, 2019, and issued a Form 483 with one observation. The inspection revealed that written standard operating procedures for collecting whole blood units were not consistently followed. Specifically, certain whole blood units were collected without the required mixer and were not immediately mixed after collection.
View Company Profile
ID · 3d1e7fb9-7cad-498e-bd9b-bf61dd17a147
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.