R3 Selling Unapproved Drugs, Biologics, FDA Says

An 11/17-12/16/2025 FDA inspection at the R3 Medical Companies’ Bello Bio and Regen Suppliers units in Scottsdale, AZ, documented that Bello contract manufactures and labels several umbilical cord-derived products and Regen approves, labels, stores, and distributes the Bello products and an umbilical cord product contract manufactured by a redacted entity. An 8/14 Warning Letter says that legally, the firm’s products are unapproved new drugs and unlicensed biologics.

FDA says it appears from various sources that the products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or conditions in humans and/or are intended to affect the structure or function of the body. The agency notes that the products do not have approved BLAs that are required for human cells, tissues, or cellular or tissue-based products.

The Warning also lists these significant current good manufacturing practice (CGMP) violations:

• failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including procedures for validation of all aseptic and sterilization processes;
• failure to establish written procedures for production and process control designed to assure that drug products have the identity, strength, quality, and purity that they are purported or represented to possess;
• failure to establish laboratory controls that include scientifically sound and appropriate specifications, standards, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity;
• aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions;
• failure to establish and follow a written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates; and
• failure to have in writing and fully follow the responsibilities and procedures applicable to the quality control unit.

FDA says the firm’s responses to the Form FDA-483 inspection observations were not adequate to remedy the stated violations. R3 was told to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.