Biolife Plasma Services L.P. – FDA EIR, May 18, 2023

An FDA inspection of BioLife Plasma Services L.P. in Loveland, CO, was conducted from May 15 to May 18, 2023. This comprehensive inspection, guided by Compliance Program 7342.002 for source plasma establishments, revealed a critical observation documented on an FDA-483 form. The main violation, referencing 21 CFR 630.10(d)(4), involved the facility's failure to adequately determine donor eligibility. Specifically, staff did not properly document donor tattoos and piercings during physical assessments. Incidents included a donor whose recent tattoo and prior piercings were not recorded over multiple visits, and another donor with several ear lobe piercings where only a single one was documented initially. This indicates a gap in following established physical examination procedures, affecting the thoroughness of donor screening. Additionally, two discussion items were raised: an instance of an employee not fully adhering to standard operating procedures for verifying plasma container setup during a donation, and a plasmapheresis machine displaying an incorrect date and time, indicating a lack of equipment standardization. Management initiated actions, including deferring one donor and correcting the machine's time. BioLife Plasma Services L.P. is required to submit a formal written response to the FDA within 15 days, outlining their corrective and preventive actions to ensure compliance with regulatory standards for donor safety and product quality.