FDA 483 - NIH Donor Center at Fishers Lane - July 11, 2019

The FDA inspected the NIH Donor Center at Fishers Lane in Rockville, MD, from July 8-11, 2019, revealing significant issues related to donor safety and procedural compliance. Observations included the failure of physicians to explain plateletpheresis risks to donors, inadequate collection of donor contact information, and a general failure to consistently follow written standard operating procedures for blood and blood component collection. These findings indicate deficiencies in donor consent processes and adherence to established protocols.