HRF, Inc – FDA 483, Mar 20, 2019

An FDA inspection of BRP, Inc, a source plasma donor center in Raleigh, NC, revealed significant deficiencies in donor screening and record-keeping practices. Observations included failures to correctly assess donor hematocrit values according to current regulations, lack of concurrent documentation for donor rechecks, and inadequate standard operating procedures for determining donor eligibility. These issues indicate a need for improved compliance with donor qualification and record-keeping requirements.