On August 14, 2026, the U.S. Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) issued a Warning Letter to R3 Medical Companies, which includes Bello Bio, Regen Suppliers, and affiliated entities.

The letter documents several violations, notably the distribution of unapproved or unlicensed biological products, raising significant regulatory concerns.

Additionally, the FDA inspection identified critical deficiencies in current good manufacturing practices (CGMP), underscoring areas requiring urgent corrective actions.

The inspection dates, detailed violations, and recommended measures for compliance improvement were outlined in the Warning Letter to ensure adherence to federal regulations and safeguard public health.