FDA EIR - Institutional Review Board of Franciscan Health Lafayette - October 18, 2017

An FDA inspection of the Institutional Review Board of Franciscan Health Lafayette in Lafayette, IN, was conducted from October 10-18, 2017. This directed follow-up inspection, conducted under the regulatory guidance of CPGM 7348.809 for Institutional Review Boards, aimed to assess corrective actions from previous observations.

The main violation identified was a repeat deficiency: the failure to conduct continuing review of research studies at intervals of not less than once per year, citing three specific studies. This finding reiterates a non-compliance with 21 CFR 56.109(f), which was also observed in prior inspections concluding in December 2014 and February 2013, each resulting in an FDA 483 and/or Untitled Letters. While an earlier issue regarding the maintenance of comprehensive IRB member rosters had been successfully addressed, the critical lapse in annual research review persisted despite previous commitments for corrective measures.

In response to the current observations, the IRB committed to providing a detailed corrective action plan within 15 business days. Additionally, management revealed intentions to centralize IRB review functions within the broader Franciscan Alliance system by January 2018, aiming for enhanced system-wide oversight and compliance.