Dae Seung Co., Ltd.
⚠️ Moderate Risk
FEI: 3004606451 • Jeju-Do • SOUTH KOREA
FEI Number
3004606451
Location
Jeju-Do
Country
SOUTH KOREAAddress
1696, Jochun-Ri, Jochun-Eup, , Bukjeju-Gun, Jeju-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
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).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/28/2011 | 80FQMBANDAGE, ELASTIC | Division of West Coast Imports (DWCI) | |
| 12/28/2011 | 80FQMBANDAGE, ELASTIC | San Francisco District Office (SAN-DO) | |
| 3/23/2007 | 62MAJ08MENTHOL (ANTI-PRURITIC) | New York District Office (NYK-DO) | |
| 5/12/2006 | 80FQMBANDAGE, ELASTIC | Los Angeles District Office (LOS-DO) | |
| 5/12/2006 | 80FQMBANDAGE, ELASTIC | Los Angeles District Office (LOS-DO) | |
| 10/4/2005 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Dae Seung Co., Ltd.'s FDA import refusal history?
Dae Seung Co., Ltd. (FEI: 3004606451) has 6 FDA import refusal record(s) in our database, spanning from 10/4/2005 to 12/28/2011.
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. Dae Seung Co., Ltd.'s FEI number is 3004606451.
What types of violations has Dae Seung Co., Ltd. received?
Dae Seung 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 Dae Seung Co., Ltd. come from?
All FDA import refusal data for Dae Seung 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.