FDA 483 - Duke Medical Center-Carolinas Cord Blood Bank and Stem Cell Laboratory - August 02, 2019

Duke University, a biologic manufacturer in Durham, NC, was cited for significant deficiencies during an FDA inspection. The firm failed to adequately document corrective and preventive actions, maintain an effective environmental monitoring program, and qualify cleaning procedures. Additionally, issues were noted with the alarm system, quality unit oversight of batch records, control over critical materials, inventory management, data protection for computerized systems, and the timely completion of equipment performance qualifications.