FDA 483 - International Medsurg Connection, Inc. - October 17, 2025

International Medsurg Connection, Inc., a specification developer located in Schaumburg, IL, was subject to an FDA inspection from October 14 to October 17, 2025. The inspection revealed a significant deficiency in the company's Medical Device Reporting (MDR) procedures. Specifically, the firm's written MDR procedure lacked an adequate internal system for ensuring the timely and effective communication of events that necessitate reporting to the FDA. Although the procedures outlined initial report submissions, they failed to incorporate requirements for filing supplemental reports, as evidenced in their Complaint Management System Procedures (SOP-000020, Rev 09, 12/16/2022). This issue is particularly notable as the company manufactures Class 2 Medical Device Surgical Drapes and this was a repeat discussion item from a previous FDA inspection in 2023. The observation indicates a non-conformance with the regulatory framework for medical device quality systems and adverse event reporting. While the FDA 483 document serves as an observation report, it mandates that the company implement corrective actions to address these procedural gaps and ensure full compliance. The firm acknowledged the observation and promised to correct it, bearing the responsibility for internal audits to identify and rectify all quality system violations.