TRACLE INC
⚠️ Moderate Risk
FEI: 3019672765 • Goyang, Gyeonggi • SOUTH KOREA
FEI Number
3019672765
Location
Goyang, Gyeonggi
Country
SOUTH KOREAAddress
Paju, Gyeonggi 10239; 801 1072-1 Yadangng; Ilsanseo District, Goyang, Gyeonggi, 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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/5/2022 | 53LG08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 1/5/2022 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 1/5/2022 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is TRACLE INC's FDA import refusal history?
TRACLE INC (FEI: 3019672765) has 3 FDA import refusal record(s) in our database, spanning from 1/5/2022 to 1/5/2022.
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. TRACLE INC's FEI number is 3019672765.
What types of violations has TRACLE INC received?
TRACLE INC has been cited for 3 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 TRACLE INC come from?
All FDA import refusal data for TRACLE INC 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.