FDA 483 - KEN Hygiene Systems A/S - June 29, 2023

The FDA conducted an inspection of KEN Hygiene Systems A/S, a medical device manufacturer, from June 26 to June 29, 2023. This inspection led to the issuance of a Form FDA 483, detailing three observations concerning the company's adherence to quality system requirements. The primary issues identified included inadequate procedures for controlling nonconforming products, where components failing inspection were stored without proper identification alongside acceptable inventory and not registered in the nonconformance system. Specific examples involved parts with out-of-tolerance dimensions and excess weld material. Furthermore, the inspection revealed deficiencies in documentation practices. Rework and subsequent reevaluation activities performed on nonconforming components, such as those with excess weld material, were not adequately recorded in the device history records. Additionally, physical or electronic copies of labels, including Unique Device Identification (UDI) labels, for certain finished products were not sufficiently maintained within the device history records. KEN Hygiene Systems A/S has acknowledged these observations and committed to implementing corrective actions for all identified deficiencies.