FDA 483 - Bello Bio LLC - December 16, 2025

Bello Bio LLC, a manufacturer of human umbilical cord tissue products, received a Form 483 citing numerous significant deficiencies across its operations. These include a complete absence of a quality control unit, lack of validated aseptic processes and manufacturing procedures, and failures in environmental monitoring, stability testing, and complaint handling. The firm also lacked proper donor eligibility documentation and controls over labeling and product quarantine, indicating systemic issues in quality assurance and regulatory compliance.