FDA WARNING_LETTER - Joseph-Vempilly, Jose, MD - October 11, 2012

The FDA issued a Warning Letter to Jose Joseph-Vempilly, M.D., following an inspection from September 13 to October 11, 2012, regarding the clinical investigation of Protocol HZA106837 for GlaxoSmithKline. The inspection, part of the Bioresearch Monitoring Program, identified significant violations of FDA regulations.

Dr. Joseph-Vempilly failed to ensure the investigation was conducted according to the investigational plan (21 CFR 312.60). Specifically, four subjects (00621, 00624, 00625, 00626) were not excluded from randomization despite not meeting the required inhaled corticosteroid usage criteria. Additionally, Subject 00638 continued using a prohibited leukotriene antagonist after Visit 1. These protocol deviations jeopardized subject safety and data validity.

Furthermore, Dr. Joseph-Vempilly failed to maintain adequate and accurate case histories (21 CFR 312.62(b)). Blood pressure, pulse rate, and body temperature readings were recorded for subjects 00621, 00623, and 00628 when these measurements were not taken, as acknowledged in the October 16, 2012, response. This falsification compromised data integrity.

While the response indicated the termination of the research coordinator