FDA WARNING_LETTER - Kennedy, Philip R. - October 16, 2019

This Warning Letter details objectionable conditions observed during an FDA inspection of Dr. Kennedy's clinical site from October 2-16, 2019. The inspection assessed compliance as a sponsor-investigator for the significant risk clinical study "(b)(4)", Investigational Device Exemption (IDE) (b)(4), involving a device defined under section 201(h) of the Federal Food, Drug, and Cosmetic Act.

Violations of 21 CFR Part 812 (Investigational Device Exemptions) and Part 50 (Protection of Human Subjects) were identified. Key deficiencies include:

1. **Failure to ensure proper monitoring and IRB review/approval [21 CFR 812.40]:** No documentation of monitoring was found. No IRB continuing review was conducted from 2002 to 2019, despite continued enrollment and data collection. The provided response was deemed inadequate, lacking documentation and a recurrence prevention plan.

2. **Failure to submit complete and accurate progress reports [21 CFR 812.150(b)(5)]:** No correspondence with an IRB occurred from February 13, 2009, to the end of the 2019 inspection, and no progress reports for multiple years (2010-2012, 2014-2018) were submitted to the