FDA 483 - Biolife Plasma Services L.P. - May 18, 2023

Biolife Plasma Services L.P. in Loveland, CO, received a Form 483 observation related to donor eligibility determination. The inspection found that the facility failed to adequately document tattoos and piercings during physical assessments of donors, leading to an inadequate assessment of donor eligibility before plasma collection. This indicates a lapse in adherence to established physical examination procedures.