Dxm Co Ltd
⚠️ Moderate Risk
FEI: 3004993132 • Gyeonggi-Do • SOUTH KOREA
FEI Number
3004993132
Location
Gyeonggi-Do
Country
SOUTH KOREAAddress
No. 1016, Ilsantechnotown Bldg.1141-1, , Goyang-Si, Gyeonggi-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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/26/2006 | 76MZWDENTAL CEMENT WITHOUT ZINC-OXIDE EUGENOL AS AN ULCER COVERING FOR PAIN RELIEF | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/26/2006 | 76MZWDENTAL CEMENT WITHOUT ZINC-OXIDE EUGENOL AS AN ULCER COVERING FOR PAIN RELIEF | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/26/2006 | 76MZWDENTAL CEMENT WITHOUT ZINC-OXIDE EUGENOL AS AN ULCER COVERING FOR PAIN RELIEF | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/26/2006 | 76MZWDENTAL CEMENT WITHOUT ZINC-OXIDE EUGENOL AS AN ULCER COVERING FOR PAIN RELIEF | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/26/2006 | 76DZMNEEDLE, DENTAL | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/26/2006 | 76DZMNEEDLE, DENTAL | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/26/2006 | 76MZWDENTAL CEMENT WITHOUT ZINC-OXIDE EUGENOL AS AN ULCER COVERING FOR PAIN RELIEF | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/26/2006 | 76DZMNEEDLE, DENTAL | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/26/2006 | 76DZMNEEDLE, DENTAL | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/26/2006 | 76DZMNEEDLE, DENTAL | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/26/2006 | 76DZMNEEDLE, DENTAL | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/26/2006 | 76DZMNEEDLE, DENTAL | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Dxm Co Ltd's FDA import refusal history?
Dxm Co Ltd (FEI: 3004993132) has 12 FDA import refusal record(s) in our database, spanning from 6/26/2006 to 6/26/2006.
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. Dxm Co Ltd's FEI number is 3004993132.
What types of violations has Dxm Co Ltd received?
Dxm Co Ltd has been cited for 1 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 Dxm Co Ltd come from?
All FDA import refusal data for Dxm 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.