FDA WARNING_LETTER - Ward, John A., M.D. - May 20, 2009

This FDA Warning Letter, dated December 3, 2009, was issued to John A. Ward, M.D., of Capstone Clinical Trials, Inc., following an inspection conducted between May 12 and May 20, 2009. The inspection reviewed Dr. Ward's conduct of a clinical investigation (Protocol (b)(4)) for an investigational drug.

The FDA concluded that Dr. Ward failed to adhere to statutory requirements and FDA regulations governing clinical investigations and human subject protection. Two key violations were identified:

1. **Failure to ensure the investigation was conducted according to the investigational plan [21 CFR 312.60]:** The protocol required preoperative randomization, but subjects were randomized postoperatively. This deviation was reported to the IRB for subjects 5001-5139, and continued for subsequent subjects (e.g., 5205, 5209, 5212, 5215, 5223, 5229) even after May 30, 2007. Dr. Ward's response claiming preoperative randomization after May 11, 2007, was deemed unacceptable due to lack of supporting documentation.

2. **Failure to ensure IRB compliance for initial and continuing review [21 CFR 312.66]:** Research activities continued during