Warning letterPosted September 30, 2025
FDA warning letter to Insung Medical Co. Ltd.
Medical Device Reporting/Misbranded
FDA posted a warning letter to Insung Medical Co. Ltd. on September 30, 2025; the letter is dated September 23, 2025. Subject: Medical Device Reporting/Misbranded. Issuing office: Center for Devices and Radiological Health.
On the record
- Company
- Insung Medical Co. Ltd.
- Subject
- Medical Device Reporting/Misbranded
- Issuing office
- Center for Devices and Radiological Health
- Letter dated
- 2025-09-23
- Posted by FDA
- 2025-09-30
- Source
- FDA warning letters ↗
CFR cited
The record cites 4 sections of 21 CFR Part 803.
The full record
An account shows the violations FDA described and each CFR section it cited.
What a warning letter is
A warning letter is FDA's notice to a company that it found significant violations of federal requirements. FDA asks for a written response, normally within 15 working days. The letter is advisory: it states the agency's position and is not a final agency action.
More
Watch Insung Medical Co. Ltd
A free account shows the last 7 days of every record. Pro adds a watchlist: one email when FDA acts on a company you name.
From FDA warning letters. The record may have changed since it was read.
Approve Suite is not affiliated with FDA, or with Insung Medical Co. Ltd.
See something wrong on this page? Write to info@approvesuite.com and we will check it against the source. How corrections work.