FDA 483 - LightTech Lamp Technology Ltd. - June 09, 2023

An FDA inspection conducted from June 5-9, 2023, at LightTech Lamp Technology Ltd., a medical device manufacturer located in Dunakeszi, Hungary, revealed significant deficiencies in their quality management system. The inspection resulted in a Form FDA 483, detailing four key observations. The primary issues centered on inadequate documentation and established procedures. Specifically, the firm failed to adequately document corrective and preventive action (CAPA) activities, lacking details on root cause investigations, specific actions taken, and verification of their effectiveness. Furthermore, the company did not adequately maintain its device master records, failing to compile a comprehensive list of contents or keep records in a central location. Crucially, procedures for device history records were not established, meaning there was no defined process for creating and maintaining essential production and quality information for each device. Lastly, quality audit procedures were found to be insufficient, as the internal audit programs did not include reviews of the complaint or CAPA systems. LightTech Lamp Technology Ltd. has acknowledged these observations and committed to implementing corrective actions for each identified deficiency. These actions are required to bring the firm's operations into compliance with regulatory expectations for medical device manufacturing.