Ceragem Co. Ltd. – FDA 483, May 14, 2018

Ceragem Co. Ltd., a device manufacturer in Cheonan-Si, Korea, received a Form FDA 483 for significant deficiencies in its quality system. The inspection revealed inadequate procedures for complaint handling, a lack of written Medical Device Reporting (MDR) procedures, and insufficient statistical techniques for product acceptance. These observations highlight a need for improved controls to ensure regulatory compliance and product quality.