483
Replimune, Inc.FDA 483 - Replimune, Inc.
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Record Details
Replimune, Inc. in Framingham, MA was inspected from April 17-24, 2025, resulting in two observations. The inspection found issues with untimely closure of deviation investigations and deficiencies in quality agreements with contracted sites. These conditions indicate potential weaknesses in the firm's quality system and oversight of outsourced activities.
- Company
- Replimune, Inc.
- Product Type
- Biologics
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ID · 906dfe9c-2823-4d38-b298-98d27eeee036