Michael S. Miller, D.O. – FDA Warning Letter, Nov 5, 2007

This FDA Warning Letter, dated February 12, 2008, was issued to Michael S. Miller, D.O., following an inspection from October 15 to November 5, 2007, under the Bioresearch Monitoring Program. The inspection reviewed clinical studies involving investigational drugs and devices.

The letter identifies several violations of 21 CFR Parts 50, 312, and 812. Key deficiencies include:

1. **Failure to obtain informed consent (21 CFR §§ 312.60 and 812.100):** Multiple instances across Studies 2 and 3 where informed consent forms were not signed and dated by subjects at the time of screening, or by the "Person Explaining Consent" on the same date as the subject, or were undated by the subject.

2. **Failure to conduct investigations according to the investigational plan and regulations (21 CFR §§ 312.60 and 812.100):** Numerous protocol deviations were cited across all four studies. These included randomizing subjects who met screen failure criteria (e.g., wound size changes, BMI, age, circulation issues, abnormal lab values), failing to collect required samples or perform assessments during the screening phase, continuing ineligible subjects in studies, and incorrect dispensation of test articles.

3. **Failure to maintain adequate, accurate