FDA WARNING_LETTER - Advanced Magnetic Research Institute International LLC - September 10, 2013

This Warning Letter details objectionable conditions observed during an FDA inspection of Advanced Magnetic Research Institute International, LLC (AMRI) from August 20 to September 10, 2013. The inspection assessed compliance with federal regulations for three clinical studies involving the Magnetic Molecular Energizer (MME) device.

Violations of 21 CFR Part 812 (Investigational Device Exemptions) were identified: 1. **Failure to obtain Institutional Review Board (IRB) approval:** AMRI failed to maintain IRB approval for the MME device investigations after February 2, 2008, placing subjects at increased risk. 2. **Prohibited promotion of an investigational device:** AMRI's website promoted the MME as safe and effective for various conditions (e.g., spinal cord injury, Alzheimer's, congestive heart failure), violating regulations prohibiting such claims for unapproved devices. 3. **Failure to maintain required records and submit reports:** AMRI failed to report several serious adverse events (e.g., breast cancer, deaths), provide IRB names/addresses, and maintain records on Good Manufacturing Practice (GMP) adherence for MME device manufacturing.

The FDA considers these serious violations. AMRI is required to contact the FDA within two weeks to schedule a teleconference and, within 15 working days, provide documentation of corrective actions, a plan to prevent recurrence, and a monitoring plan. Failure to