Berkeley Biologics LLC – FDA 483, Apr 29, 2026

Berkeley Biologics LLC in Richmond, CA, a human tissue establishment, received a Form 483 with six observations, including repeat findings. The inspection revealed significant deficiencies in donor eligibility determinations for communicable diseases, inadequate oversight of contract manufacturing partners, and failures in deviation investigations and procedural controls. Additionally, the firm used unqualified reagents and had poor environmental controls in its tissue processing areas.