FDA WARNING_LETTER - Dallas Jr, Anthony V, MD - April 08, 2009

The FDA issued a Warning Letter to Dr. Anthony Dallas of Family Health Care of Hendersonville following an inspection from March 16 to April 8, 2009, as part of the Bioresearch Monitoring Program. The inspection reviewed Dr. Dallas's conduct of two clinical investigations: Protocol (b)(4) for investigational drug (b)(4) and Protocol (b)(4) for investigational drug (b)(4).

The FDA concluded that Dr. Dallas failed to adhere to statutory requirements and FDA regulations governing clinical investigations, specifically citing violations of 21 CFR 312.60 and 21 CFR 312.62(b).

Key violations include: 1. **Failure to personally conduct or supervise investigations (21 CFR 312.60):** Dr. Dallas signed blank source document worksheets for subjects #0011, #008, and #003 in Protocol (b)(4), indicating a lack of review of data before signing. His reliance on the study coordinator and inadequate information flow were noted. 2. **Failure to conduct studies according to the investigator statement and investigational plan (21 CFR 312.60):** * Protocol (b)(4): Subject #0011 was allowed to continue despite using disallowed oral hormone replacement therapy (Prempro). * Protocol (b)(4