FDA EIR - Robert D. Ferrera, MD - May 22, 2008

An FDA inspection of Ferrera, R. David, MD, operating as Sacramento Medical Research Group, was conducted from May 8 to May 22, 2008. This high-priority inspection, performed under Compliance Program 7348.811 for Clinical Investigators, aimed to validate clinical investigator data for a pre-approval New Drug Application. The inspection identified critical deviations from regulatory requirements and the signed investigator agreement.

The main violations, documented on an FDA Form 483, included the improper dispensing of study medication where an incorrect drug kit (active drug instead of placebo) was issued to a subject, and the failure to report an adverse event (healing vesicular lesions) for another subject on the official Case Report Form. These issues represent a direct violation of 21 CFR 312.60.

Further observations revealed numerous recordkeeping deficiencies, such as inconsistent dating, blank data fields, uninitialed corrections, and inaccurate data transcription between source documents and CRFs. There was also inadequate documentation for protocol deviations, including the use of rescue medication or the inclusion of a subject with an undisclosed medical history. Additionally, different versions of informed consent forms were used concurrently, and the company's website contained inaccurate claims regarding prior FDA audits.

Management, represented by the Research Coordinator, acknowledged the findings and committed to improved diligence in medication dispensing, enhanced adverse event reporting procedures, and better record management practices. A written response to the inspectional findings was promised, necessitating a comprehensive review and overhaul of their clinical trial conduct and documentation processes to ensure full compliance.