FDA 483 - NEOSS AB - June 27, 2023

An FDA inspection of NEOSS AB, a medical device manufacturer in Goteborg, Sweden, was conducted from June 26-27, 2023. The inspection resulted in a Form FDA 483, outlining two key observations regarding the company's quality management system. The primary issues centered on inadequate procedures for complaint handling and quality audits, essential components of the regulatory framework governing medical devices. Specifically, NEOSS AB's complaint procedures lacked complete FDA definitions for terms like "Malfunction" and "Caused and contributed," potentially leading to incorrect reportability decisions for adverse events. Additionally, the firm's internal audit schedules for 2020 and 2023 failed to address 21 CFR Part 803, which pertains to Medical Device Reporting. While the complaint procedure issue was corrected during the inspection, the company committed to addressing the audit schedule deficiency. These observations highlight the need for NEOSS AB to enhance its quality system to ensure full compliance with FDA regulations, thereby safeguarding public health.