Warning Letter — R3 Medical Companies
The FDA issued a warning letter to R3 Medical Companies regarding the distribution of unapproved biological products following an investigation by the Center for Biologics Evaluation and Research (CBER).
R3 Medical Companies, its subsidiaries, and personnel involved in the manufacturing, marketing, and distribution of regenerative medicine or biological products.
This enforcement action indicates that CBER is actively monitoring the regenerative medicine space for products marketed without necessary biologics license applications (BLA) or investigational new drug (IND) applications. For regulatory professionals, this suggests a continued focus on ensuring that human cells, tissues, and cellular and tissue-based products (HCT/Ps) meet rigorous safety and efficacy standards rather than relying on exemptions.
Review product portfolios to determine if HCT/P products require BLA or IND oversight. Ensure all promotional claims align with established regulatory pathways and that manufacturing facilities are prepared for CBER-level inspections and quality standards.
FDA Warning Letter issued to: R3 Medical Companies. 08/14/2026 — Center for Biologics Evaluation and Research (CBER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/r3-medical-companies-726330-08142026
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