FDA WARNING_LETTER - Nemechek Do Pa, Patrick - March 22, 2010

This FDA Warning Letter, dated June 28, 2010, addresses Patrick Nemechek, D.O., PA, following an inspection from February 22 to March 22, 2010, as part of the Bioresearch Monitoring Program. The inspection reviewed the conduct of a clinical study, (b)(4), and identified violations of 21 CFR Parts 312 and 50.

Key violations include: 1. **Failure to conduct the investigation according to the signed investigator statement and investigational plan (21 CFR § 312.60):** * Seven of seventeen enrolled subjects did not meet eligibility criteria (e.g., prior hepatitis C, incorrect CD4 count, insufficient ARV stability, detectable viral load, history of myocardial infarction, abnormal serum glucose). * Protocol-required viral load and urine pregnancy tests were not performed for specific subjects. * HIV infection documentation was missing for one subject prior to study entry.

2. **Failure to obtain informed consent in accordance with 21 CFR Part 50 (21 CFR § 312.60):** * Seven subjects were reconsented using an obsolete consent form, despite IRB instructions to use an updated, IRB-stamped version (dated 11-26-07) after protocol amendment #5. *