483
Replimune, Inc.FDA 483 - Replimune, Inc.
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Record Details
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.
- Company
- Replimune, Inc.
- Product Type
- Drugs
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ID · 1dc645cd-936d-4b14-bee2-9f36dd38704a