FDA 483 - Akan Biosciences Inc - September 30, 2022

Akan Biosciences, Inc. in Gaithersburg, MD, a human tissue establishment, was cited for significant deficiencies during an FDA inspection. The firm failed to adequately test and screen donors for communicable disease agents, and its adipose tissue product, Ayama, was shipped without proper donor eligibility determination and quarantine. Additionally, the inspection revealed a lack of validated manufacturing processes, established CGTP procedures, software validation, and a comprehensive quality program for handling complaints.