Insung Medical Co. Ltd.

During an inspection of your firm located in Gangwon, Korea from April 28, 2025, through May 1, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures ANKOR Endobronchial Tube. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.

Our inspection revealed that your firm’s ANKOR Endobronchial Tubes are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 ‐ Medical Device Reporting. Significant violations include, but are not limited to, the following:

1. Failure to report the information required by § 803.52 in accordance with the requirements of § 803.12(a), no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that it markets has malfunctioned and this device or a similar device that your firm markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a)(2).

The information included for Complaint ISQC‐22‐0513‐02 reasonably suggests that your firm’s ANKOR Endobronchial Tube malfunctioned (i.e. failure of carinal cuff to inflate) during the pre‐use check. Generally, a malfunction is reportable if, among other factors, the malfunction involves a device that is considered to be life‐supporting or life‐sustaining and thus is essential to maintaining human life. See Medical Devices; Medical User Facility and Manufacturing Reporting, Certification and Registration; Final Rule, 60 Fed. Reg. 63578, 63585 (Dec. 11, 1995). The fact that the malfunction occurred once leads to the presumption that the malfunction will recur. Your firm became aware of the referenced event on May 9, 2022. However, based on our records, the FDA has not received a corresponding malfunction report for the referenced event.

Your firm’s responses dated May 19, 2025, and June 30, 2025, did not address the deficiency as it was not included on the FDA Form 483.

2. Failure to adequately develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17(a). For example, during the inspection, your firm presented a document “Medical Device Reporting Procedure (MDR)”, Document No.: MDR‐001~MDR‐003, Rev. 0, dated 2025‐01‐08, as its written MDR procedure. After reviewing the procedure, the following deficiencies were noted:

1) The MDR procedure, Rev. 0, does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements, as required by 21 CFR 803.17(a)(1). For example, there are inadequate definitions of what constitutes a reportable event under 21 CFR Part 803. The procedure does not include the definitions for terms outlined at 21 CFR 803.3, including “become aware,” “caused or contributed,” “malfunction,” and “serious injury," and the definition for the term “reasonably suggests” found in 803.20(c)(1), which may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).

2) The MDR procedure, Rev. 0, does not establish internal systems that provide for timely transmission of complete medical device reports, as required by 21 CFR 803.17(a)(3).

Specifically, your procedure does not include:

a. Instructions for how to complete the FDA 3500A form.

b. How your firm will ensure that all information reasonably known to you is submitted for each event. Specifically, which sections of the Form 3500A will need to be completed to include all information found in your firm’s possession and any information that becomes available as a result of a reasonable follow‐up within your firm.

c. The circumstances under which your firm must submit supplement or follow-up report required under 21 CFR 803.56 and the requirements for such reports. Without such procedural instructions, your firm might fail to determine when supplemental reports are necessary, provide complete information, or comply with applicable reporting timeframes.

Furthermore, it is recommended to establish an active Electronic Submissions Gateway (ESG) production account for the electronic submission of MDR reports. FDA verified that, as of July 2, 2025, your firm does not have such an account. Information about the ESG can be found at: https://www.fda.gov/medical-devices/emdr-electronic-medical-device-reporting/how-enroll-emdr-program.

Your firm’s responses dated May 19, 2025, and June 30, 2025, did not address the procedural deficiencies as these were not included on the FDA Form 483.

Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective action (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Please provide a translation of documentation not in English to facilitate our review. We will notify you regarding the adequacy of your firm’s response(s) and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.

Your firm’s response should be sent via email to Mr. Bradley Quinn at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, CMS Case #712545, when replying. If you have any questions about the contents of this letter, please contact: Ms. Kimberly Miles at Kimberly.miles@fda.hhs.gov.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.