FDA 483 - BioLife Plasma Services LP - March 25, 2022

BioLife Plasma Services LP in Aurora, CO, was inspected from March 22-25, 2022, and received one observation. The firm failed to conduct a thorough investigation into a Unit Over Nomogram (UON) event caused by apheresis equipment machine failure. Specifically, the investigation did not include corrective actions addressing the identified root cause.