FDA 483 - Burzynski Research Institute - June 06, 2006

This FDA Form 483 document details observations from an inspection of an unstated facility regarding its IND (Investigational New Drug) studies. The primary issues revolve around failures to adhere to the S.R. Burzynski Study Monitoring Plan, MQA-001 Revision A.

Key violations include: - **Failure to conduct Dynamic Audits:** No dynamic audits have been performed since 2005, despite being required by Section 12.5.1 of the Monitoring Plan. - **Inadequate Quality Assurance (QA) Monitoring:** The facility failed to monitor clinical trials as required by Sections 7.2.1, 7.2.2, and 7.2.3 of the Monitoring Plan. Specifically: - QA Monitors did not verify investigator compliance with efficacy endpoint assessments for tumor response, leading to inaccurate classifications for 18 of 27 (67%) subjects across Studies BT-09, BT-10, BT-21, and BT-22 (e.g., Subjects 005297, 007197, 06389, 11819, 009990, 006239). - QA Monitors did not properly monitor Case Report Forms (CRFs) and subject charts for data integrity. - Critical subject case history records (target tumor measurement