FDA WARNING_LETTER - Kollef, Marin H., MD - August 15, 2007

On January 28, 2008, the FDA issued a Warning Letter to Dr. Marin H. Kollef following an inspection from August 7-15, 2007, at Washington University School of Medicine. The inspection assessed compliance with federal regulations for the clinical study involving a device, [redacted] and the [redacted].

The FDA identified serious violations of 21 CFR Part 812 (Investigational Device Exemptions), Part 50 (Protection of Human Subjects), and Section 520(g) of the Act. Key deficiencies included:

1. **Failure to obtain informed consent:** Six subjects' IRB-approved consent documents lacked dates and signatures, with no evidence of legal consent or justification for its absence. The sponsor notified Dr. Kollef of this in May 2003, but the issue persisted for later subjects. Additionally, 19 subjects enrolled before March 28, 2003, used consent forms that lacked a required study flow sheet referred to in IRB-approved documents. Dr. Kollef's response, attributing issues to oversight and proposing additional training, was deemed inadequate due to a lack of timelines.

2. **Failure to ensure investigation according to plan:** Ten subjects were consented by individuals not authorized on the study personnel identification list. Dr. Kollef's response, citing supervision and oversight for missing delegation log signatures, was also inadequate