FDA WARNING_LETTER - Pinsky Mark, MD - September 28, 2012

This Warning Letter details objectionable conditions observed during an FDA inspection of Dr. Mark Pinsky's clinical site from September 17-28, 2012. The inspection assessed compliance with federal regulations for clinical studies of the (b)(4) device, specifically PMA (b)(4) and IDE (b)(4). The FDA found several violations of 21 CFR Part 812 (IDE) and Part 50 (Protection of Human Subjects).

Key violations include: 1. **Failure to conduct the investigation according to the signed agreement and investigational plan (21 CFR 812.100, 812.110(b)):** Two subjects were incorrectly randomized, receiving the wrong investigational device mix, compromising study data reliability and introducing bias. 2. **Failure to control investigational devices and maintain accurate disposition records (21 CFR 812.100, 812.140(a)(2)(ii-iii)):** No documentation existed for device disposal, and device accountability records were incomplete, posing risks of misuse. 3. **Failure to properly document and maintain informed consent (21 CFR 50.27(a), 812.140(a)(3)(i), 812.100):** 25 of 33 subjects were initially consented with an un