FDA 483 - Replimune, Inc.

An FDA inspection of Replimune, Inc. in Framingham, MA, conducted from April 17-24, 2025, identified two significant issues. The firm failed to close investigations in a timely manner, with 25% of deviations, including critical ones, exceeding the established timeframe. Additionally, quality agreements with contracted storage and testing sites were found to be deficient, lacking specific provisions for services provided.