FDA WARNING_LETTER - Frazer, Henry A. Pharm D - October 03, 2012

This FDA Warning Letter, dated June 5, 2013, addresses objectionable conditions observed during an inspection of Dr. Henry A. Frazer's clinical site from September 24 to October 3, 2012. The inspection, part of FDA's Bioresearch Monitoring Program, reviewed Dr. Frazer's conduct of two clinical investigations for investigational drugs, Protocols (b)(4) and (b)(4).

The letter identifies two primary violations:

1. **Failure to ensure investigation was conducted according to the investigational plan [21 CFR 312.60]:** * **Protocol (b)(4) violations:** * Subject 09-006 was not dispensed a LogPad as required, and five pain assessments were entered by the study coordinator, not the subject, compromising data validity. Dr. Frazer's response acknowledged this but lacked a corrective action plan. * Subject 09-006 did not meet eligibility criteria (ASA Physical Status Classification of 4 instead of 1-3, and QTc interval of 453ms instead of <450ms), jeopardizing subject safety and data integrity. Dr. Frazer failed to respond to this item or provide a corrective action plan. * Prohibited pain medications (Percocet, oxycodone) were administered to Subjects 31-