FDA WARNING_LETTER - Thurmond-Anderle, Margaret E. M.D. - August 20, 2010

An FDA inspection conducted between August 17 and August 20, 2010, by Mr. Joel Martinez, reviewed Dr. Margaret E. Thurmond-Anderle's conduct of clinical investigations for the investigational drug (b)(4) across three protocols. The inspection, part of FDA's Bioresearch Monitoring Program, concluded that Dr. Thurmond-Anderle did not adhere to applicable statutory requirements and FDA regulations governing clinical investigations. The primary violation identified was the failure to conduct studies according to investigational plans and to protect the rights, safety, and welfare of subjects, as required by 21 CFR 312.60. Specifically, an unqualified office manager inaccurately prepared study drug or placebo for infusion at approximately one-tenth of the protocol-specified dose for Protocol (b)(4), due to the mistaken use of an inappropriately-sized syringe. This dosage error compromised data reliability and subject safety. While Dr. Thurmond-Anderle outlined corrective measures in her August 23, 2010, response, she did not adequately address preventive measures to ensure only appropriately qualified individuals prepare study drugs, nor did she explain the pervasiveness of the dosage error across other protocols or subjects. The FDA requires a written response within fifteen working days detailing actions taken to prevent future violations, including additional information on preventive measures for qualified personnel and the full extent of the dosage errors. Failure to adequately respond may result in further regulatory action.