FDA WARNING_LETTER - Taber, Louise A., MD - July 18, 2014

This Warning Letter details objectionable conditions observed during an FDA inspection of Dr. Louise A. Taber's clinical site from July 7-18, 2014. The inspection, part of the Bioresearch Monitoring Program, reviewed Dr. Taber's conduct of two clinical investigations for Purdue Pharma L.P. involving the investigational drug hydrocodone bitartrate: Protocols HYD3002 and HYD3003.

The FDA identified two primary violations: 1. **Failure to maintain adequate and accurate case histories [21 CFR 312.62(b)]**: For Protocol HYD3003, audiometry reports for 4 of 19 reviewed subjects were found to be originally for other subjects. Original subject IDs and visit dates were obscured, and incorrect handwritten information was added. This raises concerns about data validity and integrity. 2. **Failure to ensure the investigation was conducted according to the investigational plan [21 CFR 312.60]**: For Protocol HYD3002, audiometry testing, a crucial safety assessment, was not performed within the required 5 days before randomization for 7 of 16 enrolled subjects. Tests were either significantly delayed or not performed at all. This jeopardized subject safety and welfare.

Dr. Taber's August 1, 2014, response to the Form FDA 483