FDA 483 - Donor Center Of Nybc - August 03, 2022

An FDA inspection of Donor Center of Nybc in Rockville Centre, NY, from July 19 to August 3, 2022, revealed that the firm failed to consistently follow its written standard operating procedures for the collection of blood and blood components. Specifically, procedures for platelet collection timing and visual inspection during medical interviews were not adhered to. This indicates a lapse in procedural compliance that could impact product quality and donor safety.