DongBang Medical Co. Ltd.
⚠️ High Risk
FEI: 3002497459 • Boryeong, Chungcheongnam • SOUTH KOREA
FEI Number
3002497459
Location
Boryeong, Chungcheongnam
Country
SOUTH KOREAAddress
Saneopdanji-Gil 30/40, Ungcheon-Eup, Boryeong, Chungcheongnam, South Korea
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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).
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.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
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).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/1/2025 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | Division of West Coast Imports (DWCI) | |
| 7/1/2024 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 5/20/2022 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 12/9/2015 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | Cincinnati District Office (CIN-DO) | |
| 9/28/2015 | 79GABNEEDLE, SUTURING, DISPOSABLE | Seattle District Office (SEA-DO) | |
| 8/1/2012 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 8/1/2012 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 8/1/2012 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | 237NO PMA | Southwest Import District Office (SWI-DO) |
| 4/27/2011 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | 508NO 510(K) | Seattle District Office (SEA-DO) |
| 3/4/2011 | 89KNMDEVICE, PRESSURE APPLYING | 223FALSE | Los Angeles District Office (LOS-DO) |
| 11/17/2010 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 11/17/2010 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 11/17/2010 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 11/17/2010 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 11/17/2010 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 11/17/2010 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 11/17/2010 | 89KNMDEVICE, PRESSURE APPLYING | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 11/17/2010 | 89KNMDEVICE, PRESSURE APPLYING | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 11/17/2010 | 89KNMDEVICE, PRESSURE APPLYING | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 11/17/2010 | 89KNMDEVICE, PRESSURE APPLYING | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 11/17/2010 | 89KNMDEVICE, PRESSURE APPLYING | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 11/17/2010 | 89KNMDEVICE, PRESSURE APPLYING | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 1/4/2006 | 80LDQDEVICE, GENERAL MEDICAL | San Francisco District Office (SAN-DO) | |
| 1/4/2006 | 80LDQDEVICE, GENERAL MEDICAL | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is DongBang Medical Co. Ltd.'s FDA import refusal history?
DongBang Medical Co. Ltd. (FEI: 3002497459) has 24 FDA import refusal record(s) in our database, spanning from 1/4/2006 to 4/1/2025.
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. DongBang Medical Co. Ltd.'s FEI number is 3002497459.
What types of violations has DongBang Medical Co. Ltd. received?
DongBang Medical Co. Ltd. has been cited for 8 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 DongBang Medical Co. Ltd. come from?
All FDA import refusal data for DongBang Medical 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.