Biomedical Regenerative GF, LLC – FDA 483, May 30, 2023

Biomedical Regenerative GF, LLC in Boca Raton, FL, was inspected and received a Form FDA 483 with six observations. The inspection revealed significant deficiencies in the firm's quality system, including failures in risk management, design control, medical device reporting, device master records, management representation, and document control. These issues indicate a lack of established and maintained procedures critical for ensuring product quality and regulatory compliance.