FDA 483 - Japan Food Research Laboratories, Chitose Laboratory

An FDA inspection of Japan Food Research Laboratories in Chitose, Japan, identified a significant issue regarding their Pyrogen Test System. The system, used for drug product testing, was found to be unvalidated, and its raw and summarized test data were stored in uncontrolled and editable MS Excel files. This raises concerns about data integrity and the reliability of test results for drug products.