FDA 483 - Golden West Biosolutions LLC - August 02, 2019

Golden West Biosolutions LLC, a blood establishment broker in Temecula, CA, was cited for significant deficiencies during an FDA inspection. Observations included a lack of written standard operating procedures for processing and storage of human serum and plasma, as well as improper storage temperatures for recovered plasma. Additionally, the firm failed to include expiration dates on container labels for pooled source plasma.