Dts Mg Co Ltd
⚠️ High Risk
FEI: 3009690622 • Seoul • SOUTH KOREA
FEI Number
3009690622
Location
Seoul
Country
SOUTH KOREAAddress
402 Daugun Indus Town 275-29, , Seoul, , 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
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/11/2012 | 79OOKDERMAL COOLING PACK/VACUUM/MASSAGER | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 9/11/2012 | 79OOKDERMAL COOLING PACK/VACUUM/MASSAGER | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 9/11/2012 | 79OOKDERMAL COOLING PACK/VACUUM/MASSAGER | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 9/11/2012 | 79OOKDERMAL COOLING PACK/VACUUM/MASSAGER | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 9/11/2012 | 79OOKDERMAL COOLING PACK/VACUUM/MASSAGER | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 9/11/2012 | 79OOKDERMAL COOLING PACK/VACUUM/MASSAGER | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 9/11/2012 | 79OOKDERMAL COOLING PACK/VACUUM/MASSAGER | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 9/11/2012 | 79OOKDERMAL COOLING PACK/VACUUM/MASSAGER | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 9/11/2012 | 79OOKDERMAL COOLING PACK/VACUUM/MASSAGER | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 9/11/2012 | 79OOKDERMAL COOLING PACK/VACUUM/MASSAGER | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 9/11/2012 | 79OOKDERMAL COOLING PACK/VACUUM/MASSAGER | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 9/11/2012 | 79OOKDERMAL COOLING PACK/VACUUM/MASSAGER | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 9/11/2012 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 9/11/2012 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 9/11/2012 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 9/11/2012 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 9/11/2012 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 9/11/2012 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 9/11/2012 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 9/11/2012 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 9/11/2012 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 9/11/2012 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 9/11/2012 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 9/11/2012 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 9/11/2012 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 9/11/2012 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 9/11/2012 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Dts Mg Co Ltd's FDA import refusal history?
Dts Mg Co Ltd (FEI: 3009690622) has 27 FDA import refusal record(s) in our database, spanning from 9/11/2012 to 9/11/2012.
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. Dts Mg Co Ltd's FEI number is 3009690622.
What types of violations has Dts Mg Co Ltd received?
Dts Mg Co Ltd has been cited for 2 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 Dts Mg Co Ltd come from?
All FDA import refusal data for Dts Mg 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.