FDA 483 - Japan Food Research Laboratories - March 29, 2023

Japan Food Research Laboratories, a contract laboratory in Ibaraki, Osaka, was cited with five observations during an FDA inspection. The observations primarily concern significant deficiencies in their quality control unit, including inadequate employee training, lack of authority for investigations, unwritten procedures, and deficient Out-Of-Specification (OOS) retesting and laboratory controls. These issues indicate a systemic breakdown in their quality management system.