BLOOD & BIOLOGICS.

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Banco de Sangre Humacao, Humacao, PR, Dec. 20, 2000 (San Juan). FDA stated that the establishment was un-licensed and had obtained and entered information required for a donor's physical exam after the donation was taken. The letter hit Banco de Sangre for accepting a donation from individual who had ingested an unspecified amount of naproxen sodium within 24 hours of a donation despite a screening requirement limiting the amount allowed within that time. According to the agency, the donor reported "that the donation was being made for therapeutic reasons," but the donation was processed into platelet concentrate and not labeled as a therapeutic donation. The unnamed investigator audited the establishment Nov. 14-28.

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Bella Vista Hospital Blood Bank, Mayaguez, PR, Jan. 19 (San Juan). The letter cited the establishment for trans-fusion of red blood cells from a whole blood unit that was initially reactive for hepatitis B core antigen (HBcAg) and for transfusion of O positive red blood cells into a patient with O negative blood type. FDA commented that the first incident involved a failure to follow a procedure dictating that reactive units of blood be placed in biohazard bags on a separate shelf in a blood storage refrigerator. The unnamed investigator audited Bella Vista December 13-18, 2000.