Replimune Limited

FDA 483 - Replimune Limited

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Record Details

Replimune Limited, a manufacturer and control laboratory in Oxford, Abingdon, United Kingdom, was cited for two observations during an FDA inspection. The inspection revealed deficiencies in method validation and calibration procedures, as well as inadequate justification for retesting analytical samples following out-of-specification results without identifying a root cause.

Company: Replimune Limited
Product Type: Biologics
Office: Office of Medical Device and Radiological Health Operations
People: Wei Wang (investigator)
Joshua Kuten

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ID · f8ae45c0-c6a4-4755-913a-0f34ef9ee072