FDA 483 - Charles River Laboratories Edinburgh Ltd. - September 01, 2025

During an inspection, Charles River Laboratories Edinburgh Ltd, a contract testing laboratory in Tranent, United Kingdom, was cited for two observations. The firm failed to establish the accuracy and reproducibility of a key analytical test method and did not validate it. Additionally, the quality control unit failed to verify and qualify an Excel spreadsheet used for calculating official test results, leading to concerns about data accuracy in computer-related systems.