FDA WARNING_LETTER - Gross, Howard M. M.D. - January 14, 2015

This Warning Letter details objectionable conditions observed during an FDA inspection of Dr. Howard M. Gross's clinical site from November 19, 2014, to January 14, 2015. The inspection reviewed clinical investigations for investigational drugs under Protocols (b)(4) and (b)(4).

The FDA concluded that Dr. Gross failed to adhere to statutory requirements and FDA regulations governing clinical investigations and human subject protection. Key violations include:

1. **Failure to ensure investigations were conducted according to the investigational plan [21 CFR 312.60]:** * **Protocol (b)(4) Eligibility Criteria:** Subjects 2102 and 2100 were enrolled despite not meeting inclusion/exclusion criteria (e.g., proteinuria without 24-hour test, concurrent Plavix use). The corrective action (SOP "Second Eligibility Check") was deemed inadequate due to lack of staff training documentation. * **Protocol (b)(4) Drug Administration:** For Subject 006, study drugs were administered in reverse order for multiple cycles. The required 30-minute observation period before administering (b)(4)/placebo was not followed for multiple cycles for Subjects 001, 003, 006, and 007. The corrective action (staff training on protocol orders) was inadequate due to insufficient detail on