FDA 483 - Mayo Clinic Hospital - December 20, 2021

The FDA inspected Mayo Clinic Hospital in Phoenix, AZ, a hospital blood bank, and issued a Form 483 with two observations. The inspection revealed significant issues with maintaining quality control and general records, including incomplete deviation investigations and missing validation documentation. Additionally, the facility failed to consistently follow its own standard operating procedures for the storage and distribution of blood and blood components, specifically regarding visual inspections.