Nishizawa Electric Meters Manufacturing Co LtdMay 19, 2023

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

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Record Details

An FDA inspection of Nishizawa Electric Meters Manufacturing Co. Ltd in Sakaki-Machi, Japan, revealed a significant issue with the firm's document control procedures. The company failed to adequately establish and maintain these procedures, specifically by not keeping document change records for several revisions. This indicates a lapse in the firm's quality system compliance.

Company: Nishizawa Electric Meters Manufacturing Co Ltd
Inspection Date: May 19, 2023
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: John A. Sciacchitano (investigator)

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ID · 71d7a0c8-d8ed-495e-90fe-4d02b7ba68f0