FDA 483 - Octapharma Plasma, Inc. - May 02, 2019

Octapharma Plasma, Inc. in Dallas, TX, received a Form 483 for failing to adequately assess donor medical history during plasma donations. The firm did not identify factors such as the use of over-the-counter medications, which could adversely affect donor health or the safety and purity of the donated plasma. This indicates a significant lapse in donor screening procedures.