FDA WARNING_LETTER - Griffin, John M.D. - July 15, 2010

The FDA issued a Warning Letter to Dr. John Griffin of Cardiovascular Associates, Ltd., following an inspection conducted between May 12 and July 15, 2010. The inspection reviewed Dr. Griffin's conduct of two clinical investigations: Protocol (b)(4) for investigational drug (b)(4) and Protocol (b)(4) for investigational drug (b)(4).

The FDA concluded that Dr. Griffin failed to adhere to statutory requirements and FDA regulations. Key violations include:

1. **Failure to Personally Conduct or Supervise:** Dr. Griffin failed to adequately supervise his research nurse, who improperly completed or signed his name on various study-related documents for both protocols, including Form FDA 1572s, non-disclosure agreements, IRB forms, and serious adverse event reports. This inadequate supervision also led to the enrollment of ineligible subjects. While Dr. Griffin initiated corrective actions, including terminating the nurse and notifying stakeholders, the FDA noted that his plan did not adequately address future supervision improvements.

2. **Failure to Conduct Studies According to Investigational Plan:** * **Ineligible Subjects:** Two subjects (00272 and 00276) in Protocol (b)(4) were enrolled despite not meeting the required inclusion criteria, specifically regarding evidence or history of atherosclerosis. * **Missed Procedures:** Subject 301082002 in Protocol (