FDA WARNING_LETTER - Horowitz, Jeffrey M.D. - September 03, 2010

On March 21, 2011, the FDA issued a Warning Letter to Jeffrey Horowitz, M.D., following an inspection from August 16 to September 3, 2010, regarding his conduct of a clinical investigation (Protocol (b)(4)) of the investigational drug (b)(4). The inspection, part of FDA's Bioresearch Monitoring Program, revealed significant violations of FDA regulations governing clinical investigations.

Key violations include: 1. **Failure to Retain Records (21 CFR 312.62(c)):** Dr. Horowitz failed to retain electronic case report forms (eCRFs), the Enrollment and Patient Status Log, and the Screening/Enrollment Log for two years after the investigation was discontinued on October 1, 2009. The sponsor took the laptop containing eCRFs, and logs were obtained from the sponsor during the inspection, indicating a lack of investigator retention. 2. **Failure to Maintain Adequate Case Histories (21 CFR 312.62(b)):** Discrepancies were found in records for both enrolled subjects. Study flowsheets documented post-dialysis vital signs instead of the required pre-dialysis vital signs, and there were inconsistencies between the Enrollment and Patient Status Log and the Screening/Enrollment Log regarding informed consent dates. These issues raised concerns about data reliability. 3. **Failure to Conduct Investigation According