FDA 483 - TERUMO YAMAGUCHI CORPORATION - March 30, 2023

This FDA Form 483 document outlines observations made during an inspection of a facility involved in the manufacturing of medical products. The inspection identified two key observations related to quality control and data integrity.

**Observation 1** addresses the inadequate sampling and testing of components. Specifically, representative samples of each batch of a "Ko) (21-))component" of the "[(o) (21- ) I" used to deliver "[(6) (21-) I Injection Solution" are not being tested. This failure means the facility is not ensuring conformance to specifications and functionality of this component with the "[(b) (4) I." This indicates a potential risk to the quality and performance of the final injection solution.

**Observation 2** concerns the lack of complete and secure backup data. The analytical equipment in the physio-chemistry laboratory is not connected to an uninterruptible power supply (UPS). This deficiency makes the instrumentation vulnerable to power loss, power surges, and brownouts. The document explicitly states that power interruptions during data acquisition can lead to data corruption, compromising the integrity and reliability of analytical results.

In summary, the observations highlight deficiencies in component quality control and data security, both critical aspects of Good Manufacturing Practices (GMP). The facility needs to implement robust sampling and testing procedures for components and ensure the security and integrity of its analytical data through appropriate power backup systems.