FDA 483 - Japan Food Research Laboratories, Chitose Laboratory - November 08, 2019

During an inspection conducted from November 5 to 8, 2019, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Japan Food Research Laboratories, a biological testing laboratory located in Chitose, Hokkaido, Japan. The inspection highlighted a significant observation concerning the firm's Pyrogen Test System, specifically the AD_Tox version 2004/03/17. The FDA noted that this critical system, used for Pyrogen Testing of various drug product lots, was not fully validated. A key deficiency identified was the system's practice of recording both raw and summarized test data into uncontrolled and editable Microsoft Excel files. This lack of data integrity meant that the summarized test data, which was directly used to determine the final test results, could be altered without proper controls. The issuance of a Form 483 by the FDA serves as notification of these inspectional observations, which suggest potential deviations from regulatory expectations. Japan Food Research Laboratories is now required to respond to the FDA, detailing the specific corrective and preventive actions they will implement to resolve these issues, ensure the validation of their testing systems, and maintain data integrity for all future analyses.