FDA 483 - KBI Biopharma, Inc.

An FDA inspection of KBI Biopharma, Inc. in Durham, North Carolina, revealed significant deficiencies in the temperature qualifications of their GMP ambient storage areas. Critical materials, including resins for Drug Substance Intermediate (DSI) production, microbial testing materials, and reagents for characterization, were found stored in unqualified ambient conditions. This indicates a serious lapse in maintaining appropriate environmental controls for sensitive manufacturing and testing components.