FDA 483 - Nishizawa Electric Meters Manufacturing Co Ltd - May 19, 2023

An FDA inspection was conducted at Nishizawa Electric Meters Manufacturing Co Ltd from May 18-19, 2023, resulting in an FDA Form 483. The primary observation noted was a deficiency in the company's document control procedures. Specifically, the inspection revealed that document change records were not adequately maintained for revisions of several key records, identified as 1075-D1-05 through 1075-D1-09. This indicates a failure to properly track modifications to essential operational documents. The regulatory framework for this observation falls under the Federal Food, Drug and Cosmetic Act, Section 704(b), which outlines the reporting of conditions that may signify non-compliance. While the FDA Form 483 is not a final determination, it serves as notification of significant observations. The company is required to investigate these findings, implement comprehensive corrective actions to address the identified quality system violations, and is expected to provide a response to the FDA detailing its plans and actions to rectify the observed deficiencies and ensure compliance with regulatory standards.