FDA 483 - IDS LTD - August 23, 2024

IDS LTD, a medical device manufacturer in Paju, Korea, was cited with five observations during an FDA inspection from August 19-23, 2024. The inspection revealed significant issues with laser product safety features, including remote interlocks and emission indicators, as well as deficiencies in quality system procedures for complaint handling, software validation, and corrective and preventive actions. These findings indicate a need for comprehensive improvements in product design controls and quality management systems.