FDA 483 - Charles River Laboratories Edinburgh Ltd. - September 02, 2025

An FDA inspection conducted on September 1-2, 2025, at an unnamed firm, resulted in the issuance of a Form 483 citing two significant observations related to quality control and data integrity. This document, issued to Mr. David Macpherson, Senior Director Laboratory Sciences, highlights areas where the firm's practices require improvement to ensure product quality and regulatory compliance. The first observation noted that the accuracy and reproducibility of a critical test method, SNNI3-002, had not been properly established. Specifically, the quality control unit failed to validate this analytical test method, as observed on December 1, 2023. This lapse raises concerns about the reliability of testing results for drug substances. The second observation identified issues with the verification of computer-related systems used for calculations. The firm's quality control unit did not verify and qualify the Microsoft Excel spreadsheet employed for calculating and quantifying official test results of samples in drug substance. This deficiency indicates a lack of control over critical data processing, potentially impacting the accuracy of product specifications and release decisions. These observations underscore the need for robust quality management systems, particularly in analytical method validation and data integrity controls for computer-generated records. The firm is required to address these findings by developing and implementing appropriate corrective and preventive actions to meet regulatory expectations.