FDA WARNING_LETTER - Sirakoff, Dimitri - February 06, 2013

This Warning Letter to Dr. Dimitri Sirakoff details objectionable conditions observed during an FDA inspection from January 9 to February 6, 2013, concerning clinical investigations for Protocols 1VIT09031 (ferric carboxymaltose) and (b)(4) ((b)(4)). The inspection, part of FDA's Bioresearch Monitoring Program, found that Dr. Sirakoff failed to adhere to statutory requirements and FDA regulations governing clinical investigations, specifically 21 CFR 312.60.

Key violations include: 1. **Failure to ensure investigations were conducted according to the investigational plan:** * **Inclusion/Exclusion Criteria Violations:** For Protocol (b)(4), four subjects (1107-1045, 1107-1057, 1107-1060, 1107-1062) were enrolled despite not meeting the Kellgren-Lawrence x-ray grade > 2 requirement for osteoarthritis diagnosis. Late entries were made to records without supporting documentation to make subjects appear eligible. * **WOMAC Pain Score Violations:** Subject 1107-1045 was randomized before eligibility assessment and had a WOMAC pain score of 4.0, below the required > 5. Subject 1107-1053 also had