FDA EIR - Syneos Health - April 01, 2022

The FDA conducted a comprehensive, pre-announced inspection of Syneos Health, a contract research organization (CRO) in Morrisville, NC, from March 28 to April 1, 2022. The inspection was assigned by the Good Clinical Practice Assessment Branch, CDER, and followed the Compliance Program Guidance Manual CPGM 7348.810, which governs Bioresearch Monitoring for Sponsors, CROs, and Monitors. The scope focused on Syneos Health’s role in a specific investigational drug study, including their procedures, sponsor contract, clinical monitoring plan, and oversight of clinical investigator sites. While a previous 2019 inspection had noted improper monitoring at individual sites, the current inspection concluded without the issuance of a Form FDA-483, indicating that no significant objectionable conditions were found in Syneos Health's operations. Although the inspection documented minor quality issues at various study sites, such as missing prescriptions, inappropriate patient data disclosure, and missed assessments, these did not result in formal citations against Syneos Health. The inspection report and collected exhibits will be forwarded to CDER for final review and classification, with no immediate corrective actions mandated for Syneos Health.