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

Berkeley Advanced Biomaterials, LLC, a tissue processor in Berkeley, CA, received an FDA Form 483 with three observations during an inspection from November 15-22, 2024. The firm was cited for failing to prevent contamination and cross-contamination during HCT/P processing, lacking environmental monitoring for bone processing, and maintaining inadequate records for cleaning, equipment use, and product compounding. These issues indicate significant deficiencies in the firm's quality control and record-keeping practices.