FDA EIR - BioLife Plasma Services L.P. - November 09, 2018

This FDA inspection report details findings for B Positive National Blood Services College Park, LLC, following an inspection conducted from November 7 to November 9, 2018. The inspection was carried out under Compliance Program 7342.002, which governs Source Plasma Establishments, to assess various operational aspects including quality assurance, donor eligibility, product testing, and collection procedures. Notably, the current inspection did not result in an FDA-483, "Inspectional Observations," signifying that no formal violations requiring immediate written notice were identified. This contrasts with a prior October 2016 inspection which cited three issues related to vital sign monitor cuff placement, inconsistent supply usage, and failure to obtain updated donor contact information. The current report confirmed that all previous observations and discussion items have since been corrected. However, the 2018 inspection highlighted two significant discussion items. First, the firm did not adhere to its own standard operating procedures regarding the timely notification of two donors concerning their positive confirmatory test results for Hepatitis B and C. Second, a quality manager prematurely expired a donor's deferral status, which was established due to an adverse reaction, contrary to the medical director's instructions and without proper explanation. Management acknowledged these lapses. Although no formal actions were mandated, B Positive National Blood Services College Park, LLC is implicitly required to review and strengthen its adherence to internal protocols for donor notification and deferral management to prevent recurrence and ensure ongoing compliance.