FDA 483 - Japan Food Research Laboratories, Chitose Laboratory

An FDA inspection of Japan Food Research Laboratories, a contract testing laboratory in Chitose-shi, Hokkaido, revealed significant deficiencies. Observations included inadequate controls for electronic records, such as lack of unique administrator IDs, unverified data retrieval, common passwords, and infrequent password changes. Additionally, the firm lacked detailed written procedures for sample testing and its quality control unit demonstrated insufficient authority to properly investigate deviations and out-of-specification results.