FDA WARNING_LETTER - Insung Medical Co. Ltd. - May 01, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Insung Medical Co. Ltd. following an inspection of their Gangwon, Korea facility from April 28 to May 1, 2025. The inspection identified significant violations concerning their ANKOR Endobronchial Tubes, classifying them as misbranded under the Federal Food, Drug, and Cosmetic Act, specifically regarding Medical Device Reporting (MDR) regulations (21 CFR Part 803).

The primary issues include the company"s failure to report a device malfunction within the required 30-day timeframe. An ANKOR Endobronchial Tube experienced a carinal cuff inflation failure in May 2022, an event for which no corresponding malfunction report was submitted, despite the device being life-supporting and the malfunction likely to recur.

Furthermore, Insung Medical Co. Ltd. failed to adequately develop, maintain, and implement written MDR procedures. Their current procedures lacked essential components, such as clear definitions for reportable events (e.g., "malfunction," "serious injury"), and adequate instructions for the timely and complete submission of medical device reports, including how to complete FDA forms and when to submit supplemental reports. The FDA also noted the absence of an Electronic Submissions Gateway account for electronic reporting.

The FDA requires Insung Medical Co. Ltd. to provide a written response within fifteen business days, outlining specific corrective actions taken to address these violations, including systemic improvements, and a plan to prevent recurrence. Documentation of these actions and a timetable for completion are also requested.