483
Charles River Laboratories Edinburgh Ltd.Charles River Laboratories Edinburgh Ltd. – FDA 483, Sep 1, 2025
Record Details
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.
View Company Profile
ID · 87f798ec-e10e-49b0-8dc2-73a817cc6d8b
Other documents for Charles River Laboratories Edinburgh Ltd.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.