483
Wakai, Ronald, Ph. D., Clinical InvestigatorFDA 483 - Wakai, Ronald, Ph. D., Clinical Investigator - August 22, 2014
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Record Details
Ronald Wakai, Ph. D., Clinical Investigator, was inspected regarding an investigational device study. The inspection revealed significant deficiencies in study conduct, monitoring, record-keeping, and informed consent processes. These issues indicate a lack of adherence to the investigational plan, signed agreements, and applicable FDA regulations, impacting subject safety and data integrity.
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ID · a2e4d45c-2f03-4fc4-a1bc-58ccd9d6c59f