FDA 483 - Octapharma Plasma, Inc. - September 23, 2019

An FDA inspection of Octapharma Plasma, Inc.'s Source Plasma Donor Center in Forestville, MD, revealed a critical failure to maintain donor records. Specifically, the firm did not retain notification letters for deferred donors who tested positive for serious communicable diseases like HIV, HCV, and HBsAg. This lapse in record-keeping raises concerns about proper donor management and public health safety.