Dongmun Co., Ltd
⚠️ Moderate Risk
FEI: 3004453295 • Kyongki Do • SOUTH KOREA
FEI Number
3004453295
Location
Kyongki Do
Country
SOUTH KOREAAddress
1141-2 Baeksuk Dong Ilsan Ku Goyang Si, , Kyongki Do, , South Korea
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/16/2015 | 90IZGSYSTEM, X-RAY, PHOTOFLUOROGRAPHIC | Florida District Office (FLA-DO) | |
| 10/9/2014 | 90IZGSYSTEM, X-RAY, PHOTOFLUOROGRAPHIC | Florida District Office (FLA-DO) | |
| 12/10/2012 | 90IZGSYSTEM, X-RAY, PHOTOFLUOROGRAPHIC | Florida District Office (FLA-DO) | |
| 12/10/2012 | 90IZGSYSTEM, X-RAY, PHOTOFLUOROGRAPHIC | Florida District Office (FLA-DO) | |
| 12/10/2012 | 90IZHSYSTEM, X-RAY, MAMMOGRAPHIC | 47NON STD | Florida District Office (FLA-DO) |
| 10/24/2011 | 90IZGSYSTEM, X-RAY, PHOTOFLUOROGRAPHIC | Florida District Office (FLA-DO) | |
| 1/13/2011 | 90IZGSYSTEM, X-RAY, PHOTOFLUOROGRAPHIC | Florida District Office (FLA-DO) | |
| 8/11/2008 | 90IZLSYSTEM, X-RAY, MOBILE | Florida District Office (FLA-DO) | |
| 5/16/2006 | 79GDYGAUZE, NONABSORABLE, X-RAY DETECTABLE (INTERNAL SPONGE) | Florida District Office (FLA-DO) | |
| 3/7/2006 | 79GDYGAUZE, NONABSORABLE, X-RAY DETECTABLE (INTERNAL SPONGE) | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/7/2005 | 79GDYGAUZE, NONABSORABLE, X-RAY DETECTABLE (INTERNAL SPONGE) | 47NON STD | Division of Southeast Imports (DSEI) |
| 3/29/2004 | 90IZLSYSTEM, X-RAY, MOBILE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Dongmun Co., Ltd's FDA import refusal history?
Dongmun Co., Ltd (FEI: 3004453295) has 12 FDA import refusal record(s) in our database, spanning from 3/29/2004 to 1/16/2015.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Dongmun Co., Ltd's FEI number is 3004453295.
What types of violations has Dongmun Co., Ltd received?
Dongmun Co., Ltd has been cited for 6 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Dongmun Co., Ltd come from?
All FDA import refusal data for Dongmun Co., Ltd is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.