FDA 483 - Sonesta Medical AB - June 07, 2023

During an FDA inspection conducted from June 5-7, 2023, Sonesta Medical AB, a medical device manufacturer in Solna, Sweden, received a Form FDA 483 citing significant quality system deficiencies. The inspection, carried out under the Federal Food, Drug, and Cosmetic Act, identified seven observations related to regulatory compliance.Key issues included inadequate procedures for receiving and evaluating product complaints, with records often missing investigation details or Unique Device Identifiers. The company's Medical Device Reporting (MDR) procedures contained conflicting information on reporting timelines and lacked an established account for electronic submissions to the FDA.Furthermore, Sonesta Medical AB demonstrated shortcomings in its design controls, specifically lacking written procedures for resolving ambiguous design inputs, fully defining design validation requirements (e.g., evaluation on initial production units or under actual use conditions), and managing design changes. Procedures for evaluating and controlling suppliers and contractors were also found to be deficient, with long periods passing without assessment. Finally, document control practices were inadequate, including issues with electronic signatures not meeting regulatory standards (21 CFR Part 11), missing approval signatures and dates, and inconsistent document numbering. Notably, several of these observations were repeats from a previous 2017 FDA inspection, indicating persistent non-compliance. The firm is required to address these systemic issues to ensure its quality system meets regulatory standards for medical device manufacturing.