FDA EIR - ViiV Healthcare Company - February 07, 2020

ViiV Healthcare Company underwent an FDA inspection from February 3-7, 2020, at its Research Triangle Park, NC, location. This premarket original inspection, conducted by the Center for Drug Evaluation and Research (CDER) under Compliance Program Guidance Manual (CPGM) 7348.810, evaluated ViiV as a sponsor of regulated clinical studies. The review focused on Phase 3 Study 205888 for fostemsavir, an HIV-1 treatment, and covered areas like organization, clinical trial registration, investigator and monitor selection/oversight, quality assurance, safety reporting, and data handling, all regulated under the Federal Food, Drug, and Cosmetic Act.While no FDA-483 (Inspectional Observations) was issued at the inspection's conclusion, the report highlighted several issues. Two IND Safety Reports were submitted late, although this was discussed but not formally cited. Significant concerns arose regarding specific clinical investigator sites. Dr. Lalezari’s site showed GCP compliance issues, leading to an improvement plan and increased monitoring. Dr. Ballesteros's site exhibited persistent non-compliance and safety concerns, prompting increased oversight. Dr. Bartczak’s site faced persistent, serious GCP non-compliance, resulting in its closure and subject transfers. The statisticians also reviewed several investigator financial disclosures, concluding they were unlikely to affect the study's outcome.ViiV and its partners had already implemented internal corrective actions for the identified site-specific issues. The FDA indicated that any further concerns would be addressed via correspondence or a subsequent visit, implying no immediate regulatory enforcement was required based on this inspection.