FDA 483 - Tamar F. Brionez, M.D. - May 07, 2026
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Tamar F. Brionez, M.D., a clinical investigator in The Woodlands, TX, received a Form 483 for significant issues during an FDA inspection. Observations included failure to conduct an investigation according to the investigational plan, with subjects missing scheduled visits and protocol deviations not being reported. Additionally, the firm failed to maintain adequate case histories, lacking original source documentation for key data points necessary to verify study accuracy and reliability.
ID · 0288f5cf-b8d4-4c3d-9a38-e7a35f5a2e9e