FDA WARNING_LETTER - American Association of Acupuncture and Bio-Energetic Medicine - July 15, 2008

The FDA issued a Warning Letter to Fred Lam, M.D., President of the American Association of Acupuncture and Bio-Energetic Medicine, following an inspection of their Institutional Review Board (IRB) from June 24 through July 15, 2008. The inspection aimed to determine compliance with 21 CFR Part 56 (IRBs), Part 50 (Protection of Human Subjects), and Part 812 (Investigational Device Exemptions) for device investigations. The review revealed several serious violations, many of which were repeat issues dating back to 1997 and documented in a 2003 inspection.

Key violations include the failure to determine compliance for research involving children, failure to prepare and follow written procedures for research review (including device risk determination), failure to conduct continuing review, failure to ensure informed consent documents meet 21 CFR 50.25 requirements, and failure to maintain adequate documentation of IRB activities and meeting minutes. Additionally, the IRB failed to provide a clear and complete roster of its members as required. The IRB's July 29, 2008, response was deemed inadequate for lacking substantive corrective and preventative actions. The FDA requires a written response within fifteen working days detailing comprehensive corrective actions, preventative measures, copies of new SOPs/policies, training plans, and completion dates. Failure to comply could result in further regulatory action.