FDA EIR - Spectrum Plasma Inc - November 15, 2018

An FDA inspection of Golden Genesis Inc., operating as NuPlasma, a for-profit apheresis Fresh Frozen Plasma (FFP) blood center in San Marcos, TX, was conducted from October 30 to November 15, 2018. This initial inspection, performed under CPGM 7342.002 for blood banks, covered regulations outlined in 21 CFR parts 210, 211, and the 600 series. A significant finding was that the facility was not currently licensed with the FDA. The primary violation noted on an FDA-483, Inspectional Observations, involved insufficient record-keeping: apheresis machines were calibrated, but the documentation for these steps was not maintained concurrently, hindering product traceability. This specific observation was corrected during the inspection. Additionally, discussions with management addressed other operational areas. The firm ceased using W-9 forms for donor SSN verification and temporarily suspended offering HEB gift cards due to transferability concerns. Scrutiny was also placed on the company's description of a smaller FFP product bag, initially labeled as 'injectable' in their standard operating procedures and marketing, which was revised to 'aliquot' during the inspection. Golden Genesis Inc. committed to providing a written response to the FDA within 15 business days regarding the discussed items.