napoli llc ( – FDA Warning Letter, Sep 24, 2010

This Warning Letter addresses objectionable conditions observed during an FDA inspection of Napoli LLC (dba Precision Reproduction)'s Institutional Review Board (IRB) from August 24 to September 24, 2010. The inspection aimed to ensure compliance with 21 CFR Part 56, governing IRBs for device investigations, and to protect human subjects. The FDA identified several violations of 21 CFR Part 56 and Section 520(g) of the Federal Food, Drug, and Cosmetic Act. Key deficiencies include the IRB's failure to be composed of at least five members, including one with nonscientific concerns, and allowing members with conflicts of interest to participate in reviews, as required by 21 CFR 56.107(a), (c), and (e). Specifically, the IRB consisted only of the Chairman and an embryologist. Furthermore, the IRB failed to have adequate written procedures governing its functions and operations, as mandated by 21 CFR 56.108(a), (b), and (c). This includes a lack of procedures for convened meetings, reporting findings, determining review frequency, managing research changes, and promptly reporting unanticipated problems or noncompliance to the FDA and institutional officials. Napoli LLC is required to provide written documentation of corrective actions within fifteen working days, detailing plans to ensure proper IRB composition, establish and implement written procedures, and provide staff training dates. Failure to respond and take appropriate action could result in further FDA regulatory action.