FDA EIR - Bay Regional Medical Center IRB - June 04, 2010

An FDA inspection of Bay Regional Medical Center IRB in Bay City, MI, was conducted from June 2-4, 2010. This follow-up inspection, under CDER Assignment FACTS# 116987 and CP# 7348.809, aimed to evaluate the IRB's adherence to its revised procedures and federal regulations, specifically 21 CFR 56.108(a)(1) and 56.109(f). Significant violations were identified, primarily stemming from the IRB's failure to consistently follow its own written procedures. These included not assigning primary reviewers for studies as stipulated and lacking an effective tracking system for the continuing review of protocols, which resulted in an inability to produce accurate lists of studies. Consequently, the IRB failed to conduct timely continuing reviews for several research studies; notably, two studies approved in May 2009 had not been reviewed by June 2010. An FDA Form 483 was issued, outlining these objectionable conditions. Management committed to providing a written response and indicated plans to transition to a centralized IRB system, engaging consultants to establish appropriate oversight and compliance measures.