Infinite Biomedical Technologies – FDA 483, Jul 30, 2026

An FDA inspection of Infinite Biomedical Technologies in Baltimore, MD, a medical device manufacturer, revealed significant deficiencies across its quality system. Observations included inadequate design controls and risk management for product safety, ineffective corrective and preventive actions (CAPA) leading to unresolved issues and untimely MDR reporting, and insufficient resources for regulatory compliance and quality system maintenance. These issues indicate a moderate level of severity, impacting product safety and regulatory adherence.