FDA EIR - BioLife Plasma Services L.P. - July 15, 2019

During an FDA inspection conducted from July 10-15, 2019, BioLife Plasma Services L.P. in Kansas City, MO, an automated Source Plasma collection facility, received one verbal warning for an objectionable condition. This initial OBPO inspection was a Level 1 directed inspection, initiated in association with a fatality and relevant compliance program. The primary violation identified was the firm's inadequate documentation of investigations into plasmapheresis device alarms. Specifically, investigations often failed to record what the technician observed as the cause of the alarm, only the alarm type and subsequent action. This omission impacted the traceability of significant manufacturing steps and the assurance of product quality, as per regulatory requirements outlined in 21 CFR 606.100(c) and 21 CFR 606.160(a). Although no FDA Form 483 was issued, management received a verbal warning. They were advised that correcting this issue would require corporate involvement and that its recurrence in future inspections would be deemed a repeated deviation under the Food, Drug, and Cosmetic Act and the Public Health Service Act. The inspection also noted that verbal warnings from a previous 2018 pre-approval inspection, concerning risk explanations, computer validation, and device qualification, had been addressed.