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

An FDA inspection conducted from March 27-29, 2023, at Japan Food Research Laboratories, a contract laboratory located in Ibaraki, Osaka, Japan, identified several significant quality system deficiencies. The inspection report, a Form FDA 483, detailed five key observations, primarily related to the firm's quality management and laboratory controls. A primary concern was the inadequacy of employee training, with staff appearing uninformed about critical quality-related procedures, and a formal training program noted as deficient. Furthermore, the firm's quality control unit exhibited a lack of authority to thoroughly investigate errors, specifically failing to initiate investigations for Out-Of-Specification (OOS) results, and its responsibilities and procedures were insufficiently documented, including the absence of a written procedure for water sampling. Laboratory controls were also cited for issues regarding OOS results. The retesting procedure was deficient, allowing for excessive retesting without a defined endpoint, and quality agreements did not adequately address OOS scenarios. Finally, the firm lacked established procedures for validating or verifying analytical methods provided by clients, a critical aspect of ensuring data reliability. To address these observations, Japan Food Research Laboratories is expected to implement comprehensive corrective and preventive actions to enhance its quality system and ensure compliance with regulatory standards for contract laboratories.