FDA 483 - Octapharma Plasma Inc - September 10, 2021

Octapharma Plasma Inc. in Columbus, OH, was inspected and received a Form 483 with four observations related to plasma collection and processing. The observations highlight issues with donor suitability determination due to incorrect medication indications, lack of certified CPR personnel, inadequate privacy for donor examinations, and multiple instances of failure to follow written standard operating procedures. These findings indicate deficiencies in critical aspects of donor screening, facility operations, and adherence to established protocols for blood and blood component collection.