FDA 483 - Inova Health Care Services - August 07, 2019

An FDA inspection of Inova Health Care Services, a blood bank in Sterling, VA, revealed three significant observations. The firm failed to consistently follow its written standard operating procedures for blood collection, processing, and distribution, including issues with donor screening, phlebotomy, and equipment validation. Additionally, the inspection noted failures in properly presenting educational materials to donors and obtaining necessary post-donation contact information.