FDA 483 - Oishi Koseido Co., Ltd. - September 01, 2023

An FDA inspection conducted at Oishi Koseido Co., Ltd. in Tosu, Saga, Japan, from August 28 to September 1, 2023, revealed several significant observations related to compliance with manufacturing practices. The contract manufacturer was cited for deficiencies across multiple areas.

Key issues included a failure to follow established change management procedures for significant projects, such as the construction and qualification of a new manufacturing building, where changes were not drafted, reviewed, and approved appropriately, and qualification lacked proper protocols and reports. Data integrity was a major concern, with observations noting a lack of raw data for calibration, the ability for personnel to alter instrument dates/times, and the deletion of raw data and injection sequences without documented justification or comprehensive audit trail review procedures. Repeat testing without justification was also observed.

Furthermore, the company lacked a robust written program for assessing drug product stability, with the provided protocol missing essential details like test methods and sample sizes. Equipment maintenance records were found to be incomplete, with external vendor maintenance and critical monitoring data not being properly documented. Issues also extended to quality control procedures, including inadequate representative sampling plans for primary packaging materials and a lack of documented procedures for the annual visual examination of reserve samples, with examination results not being recorded.

These observations highlight a need for Oishi Koseido Co., Ltd. to implement comprehensive corrective actions to ensure their operations align with regulatory expectations for pharmaceutical manufacturing.