FDA 483 - Innosys Co., Ltd. - June 15, 2023

During an inspection conducted from June 12-15, 2023, the U.S. Food and Drug Administration (FDA) issued a Form FDA 483 to Innosys Co., Ltd., a manufacturer located in Uijeongbu, Gyeonggi-do, Korea. The inspection identified several critical issues within the company's quality management system. Key observations included a failure to adequately establish procedures for receiving, reviewing, and evaluating customer complaints. Specifically, product deficiency allegations were not properly evaluated, and complaints were canceled without documented investigation or justification, as exemplified by a lack of evidence for user mishandling or documented attempts to gather necessary information from complainants.

Furthermore, the FDA noted deficiencies in design control procedures, where initial design inputs for certain product components, such as a screw insertion tool and Velofix cage, were not adequately established at the outset and design changes lacked documented verification. The firm also lacked validated methods for monitoring water quality, specifically concerning the collection, transport, holding, and third-party testing of water samples to prevent product contamination. Lastly, Innosys Co., Ltd. failed to document the required justification, including a 'Health Hazard Assessment,' for not reporting certain correction or removal actions to the FDA. Innosys Co., Ltd. has indicated its commitment to correcting all identified observations.