FDA WARNING_LETTER - Uintah Basin Medical Center - February 01, 2008

An FDA inspection of Uintah Basin Medical Center's blood bank, conducted from January 30 to February 1, 2008, revealed deviations from current Good Manufacturing Practice (cGMP) regulations (21 CFR Part 606). These deficiencies render the facility's products adulterated under Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act. The primary violation identified was the failure to maintain and/or follow written standard operating procedures (SOPs) for the collection, processing, compatibility testing, storage, and distribution of blood and blood components (21 CFR 606.100(b)). Specific instances included a laboratory technologist issuing a unit of blood without proper patient verification, leading to a transfusion of incompatible blood and a subsequent hemolytic reaction. Additionally, a blood bank armband was incorrectly replaced, and a transfusion reaction investigation was not properly initiated. The letter also noted the requirement to report Biological Product Deviations (BPDs) under 21 CFR 606.171. Uintah Basin Medical Center is required to take prompt corrective action and respond in writing within fifteen working days, detailing steps taken to correct violations and prevent recurrence. Failure to comply may result in further regulatory action.