FDA WARNING_LETTER - Alzohalli, Opada M.D. - August 14, 2013

This FDA Warning Letter, dated July 17, 2014, addresses Dr. Opada Alzohaili regarding objectionable conditions observed during an FDA inspection from July 18 to August 14, 2013. The inspection reviewed Dr. Alzohaili's conduct of seven clinical investigations of the investigational drug Albiglutide for GlaxoSmithKline, as part of the Bioresearch Monitoring Program.

The letter identifies three main violations:

1. **Failure to protect the rights, safety, and welfare of subjects (21 CFR 312.60):** * **Delayed hyperglycemia rescue:** Subject 001 (Protocol GLP112756) experienced a three-week delay in receiving rescue medication despite meeting criteria. Subject 004 (Protocol GLP108486) had a three-week delay in rescue medication. Dr. Alzohaili's responses regarding subject non-compliance and misunderstanding of the protocol were deemed inadequate due to lack of documentation and insufficient corrective action details. * **Incorrect investigational drug dispensing:** Subject 005 (Protocol GLP112756) received a pen intended for Subject 006. Subject 007 (Protocol GLP112757) received a pen assigned to Subject 001 from a different protocol. The corrective