FDA WARNING_LETTER - Samudrala, Sreedhar - March 28, 2013

The FDA issued a Warning Letter to Dr. Sreedhar Samudrala following an inspection from March 12-28, 2013, as part of the Bioresearch Monitoring Program. The inspection reviewed Dr. Samudrala's conduct of clinical investigations for Protocol HZC113782 (fluticasone furoate) and Protocol (b)(4) ((b)(4)).

The primary violation identified was the failure to ensure the investigation was conducted according to the investigational plan, specifically regarding subject enrollment criteria for Protocol HZC113782, violating 21 CFR 312.60. Eleven of 31 subjects enrolled did not meet the required post-albuterol/salbutamol FEV1/FVC ratio of ≤0.70 at screening. Four subjects did not meet the required post-albuterol/salbutamol FEV1 between ≥50% and ≤70% of predicted normal values. Additionally, two subjects aged 60 or older did not meet the criteria for being treated for at least two specified conditions (hypercholesterolemia, hypertension, diabetes mellitus, or peripheral vascular disease).

Dr. Samudrala's April 15, 2013, response to the FDA Form 483 was deemed inadequate. The proposed corrective actions—requiring investigators to sign a document confirming inclusion/exclusion criteria met, re