James W. Baker, MD – FDA EIR, Apr 14, 2009

An FDA inspection was conducted at James W. Baker, MD, d.b.a. Baker Allergy, Asthma, & Dermatology Research Center, LLC, in Lake Oswego, OR, from April 9-14, 2009. This initial inspection was undertaken by the Center for Biologics Evaluation and Research (CBER) to assess compliance with clinical investigation regulations. The inspection, which reviewed a specific clinical study, resulted in the issuance of a Form FDA 483, detailing several objectionable conditions. Primary observations included a critical flaw in the informed consent process: the document failed to adequately describe study procedures for a newly added prophylactic treatment arm, impacting subjects who participated in this part of the study. This constitutes a deviation from informed consent requirements. Additionally, the investigation was not consistently conducted according to the approved study plan. Specifically, subject assessments were not always performed until the defined "substantial relief" of symptoms was achieved, and a Serious Adverse Event (SAE) was not reported to the sponsor immediately, as mandated by the protocol. These issues relate to the proper conduct of clinical trials. The company's management received a warning and committed to providing a written response within 30 days, outlining corrective actions to address these significant deviations and ensure future regulatory compliance.