FDA 483 - Berkeley Advanced Biomaterials, LLC - November 22, 2024

Berkeley Advanced Biomaterials, LLC, a tissue processor in Berkeley, CA, was cited with three observations during an FDA inspection. The firm failed to ensure HCT/Ps were processed without contamination, lacked environmental monitoring for bone processing, and maintained inadequate records for cleaning, equipment, and processing details. These issues indicate significant deficiencies in their quality control and documentation practices.