DEMK CO. LTD - DECO
⚠️ High Risk
FEI: 3030095835 • Kwai Chung, New Territories • HONG KONG
FEI Number
3030095835
Location
Kwai Chung, New Territories
Country
HONG KONGAddress
Rm302 Wah Tat Industrial Centre, 8 Wah Sing Street, Kwai Chung, New Territories, Hong Kong
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
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(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 |
|---|---|---|---|
| 4/16/2025 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 4/16/2025 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 4/16/2025 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 4/16/2025 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 4/16/2025 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 4/16/2025 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is DEMK CO. LTD - DECO's FDA import refusal history?
DEMK CO. LTD - DECO (FEI: 3030095835) has 6 FDA import refusal record(s) in our database, spanning from 4/16/2025 to 4/16/2025.
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. DEMK CO. LTD - DECO's FEI number is 3030095835.
What types of violations has DEMK CO. LTD - DECO received?
DEMK CO. LTD - DECO 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 DEMK CO. LTD - DECO come from?
All FDA import refusal data for DEMK CO. LTD - DECO 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.