Nasim, Golzar MD – FDA Warning Letter, Aug 22, 2007

The FDA issued a Warning Letter to Dr. Nasim Golzar following an inspection from July 24 to August 22, 2007, concerning clinical investigations of an investigational drug across three protocols. The inspection, part of the Bioresearch Monitoring Program, found that Dr. Golzar failed to adhere to statutory requirements and FDA regulations for clinical investigations and human subject protection.

Key violations include: 1. **Failure to obtain informed consent (21 CFR 50, 312.60):** Four subjects in Protocol [redacted] had baseline lab samples drawn before signing consent, and for two subjects, the time of consent was not documented, making it impossible to verify consent prior to procedures. Verbal consent was deemed inadequate. 2. **Failure to conduct studies according to approved protocols (21 CFR 312.60):** * **Protocol [redacted]:** Ten subjects failed to meet radiographic inclusion criteria for acute sinusitis; one subject was enrolled despite taking exclusionary antimicrobial agents; and nine subjects did not receive required post-treatment x-rays. * **Protocol [redacted]:** Two prematurely withdrawn subjects lacked required sputum collection and post-alternate antibiotic chest x-rays. * **Protocol [redacted]:** Two subjects lacked required sputum WBC counts; one subject lacked a complete medical history; two subjects lacked baseline urinalysis; one subject received study medication without