FDA 483 - Japan Food Research Laboratories, Chitose Laboratory - December 20, 2022

An FDA inspection conducted from December 15-20, 2022, at Japan Food Research Laboratories' Chitose Laboratory in Japan, a contract testing facility, identified significant compliance issues documented in a Form FDA 483. The inspection highlighted critical deficiencies across electronic recordkeeping, written procedures, and quality control oversight. Regarding electronic records, the facility failed to ensure data trustworthiness and reliability. Issues included non-unique administrator login credentials for data modification, audit trails lacking specific user identification, infrequent verification of data backup retrieval for FTIR instruments, and common passwords with no timeout functions for testing software. Password change justifications were also absent. Procedural inadequacies were observed in sample testing. Vague codes in pyrogen test documentation led to conflicting interpretations of animal observations. Instructions were missing for crucial steps like vortexing samples for bacterial endotoxin tests and specifying appropriate pH test strips with clear reading guidance. Furthermore, the quality control unit lacked proper authority. Investigations into deviations and out-of-specification results, including re-testing and customer notification, were initiated and completed before Quality Assurance was formally notified or documentation began. This indicates a breakdown in the quality management system. The company is required to address these observations by implementing corrective actions to ensure robust data integrity, clear operational procedures, and an effective quality oversight system in line with regulatory expectations.