483
Robert G PerryRobert G Perry – FDA 483, Nov 21, 2013
Record Details
Elite Research Institute in Miami, FL, was inspected regarding its conduct of clinical investigations. The inspection revealed significant deficiencies in the conduct and supervision of studies, including issues with investigational product storage, protocol adherence, and timely reporting of deviations. Additionally, the firm failed to maintain adequate and accurate case histories, with missing and inconsistent documentation.
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ID · 8b2cd7fb-caf7-4c06-831d-03820eb0dc26
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