FDA WARNING_LETTER - Deitz, Robert, M.D. - May 28, 2009

On April 1, 2010, the FDA issued a Warning Letter to Robert Deitz, M.D., following an inspection conducted between May 19 and 28, 2009. The inspection, part of FDA's Bioresearch Monitoring Program, reviewed Dr. Deitz's conduct of clinical investigation Protocol (b)(4) for the investigational drug (b)(4). The FDA concluded that Dr. Deitz failed to adhere to statutory requirements and FDA regulations governing clinical investigations and human subject protection.

Key violations include: 1. **Failure to maintain adequate and accurate case histories [21 CFR 312.62(b)]**: Discrepancies were found in records for all six enrolled subjects, raising concerns about data reliability. Specific issues included altered Informed Consent Forms (ICFs), conflicting dates for spirometry and ICF signatures between eCRFs and worksheets, missing pages from ICFs, and uncompleted adverse event (AE) worksheets. 2. **Failure to obtain informed consent in accordance with 21 CFR Part 50 [21 CFR 312.60]**: Subject 34002 was enrolled and administered the drug before legally effective informed consent was obtained. Additionally, for three subjects (34002, 34004, 60060), signed ICFs were unapproved sample forms. 3.