FDA WARNING_LETTER - Klein, Kevin W., M.D. - February 10, 2006

On February 6-10, 2006, the FDA conducted an investigation of two clinical trials of the investigational drug [redacted] at the University of Texas Southwestern Medical Center, led by Dr. Kevin W. Klein. The inspection, part of the Bioresearch Monitoring Program, aimed to assess research conduct, human subject protection, and data integrity.

The FDA concluded that Dr. Klein failed to adhere to statutory requirements and FDA regulations. Key violations included:

1. **Failure to follow the investigational plan (21 CFR 312.60):** Required safety variables, such as [redacted] and [redacted] values, were not consistently recorded at specified intervals during induction and maintenance of [redacted] for subjects in both protocols. The response stating missed values were due to study design was deemed insufficient, as the investigator is responsible for ensuring protocol adherence or amending it.

2. **Failure to maintain adequate drug disposition records (21 CFR 312.62(a)):** Operating room pharmacy logs for [redacted] preparation and dispensing were not kept. Records for partially used and discarded vials of [redacted] and [redacted] were inadequate, preventing verification of administered amounts. The proposed improvement of using an Operating Room Pharmacy Log for future trials was deemed insufficient.

3. **Failure to maintain accurate and adequate case histories (21 CFR 312.62(