Lights Medical Manufacture Co Ltd – FDA 483, Apr 5, 2024

During an FDA inspection conducted from November 4 to November 8, 2024, Lights Medical Manufacture Co., Ltd, a drug manufacturer located in Tianjin, China, received a Form FDA 483. This document outlines significant observations made by FDA investigators regarding the firm's adherence to regulatory standards for drug manufacturing.

The inspection identified two primary issues. Firstly, the company failed to fully follow its established quality unit procedures, specifically concerning change control. It was observed that no change control documentation existed for a Potentiometric Titrator and a pH Meter, both critical pieces of equipment used to test the assay and pH of finished over-the-counter (OTC) drug products. The firm's own Standard Operating Procedure requires change control for all equipment impacting product quality.

Secondly, the inspection revealed that the firm did not maintain written records of major equipment use in individual equipment logs for manufacturing equipment involved in producing OTC drug products. This indicates a lapse in essential record-keeping practices for critical manufacturing processes.

These observations highlight deficiencies in the company's quality management system and control over manufacturing and testing equipment. Lights Medical Manufacture Co., Ltd is expected to address these findings and provide a comprehensive response to the FDA detailing its corrective and preventive actions.