SMART CHEM HYGEINE
⚠️ Moderate Risk
FEI: 3021559140 • Dubai • SAUDI ARABIA
FEI Number
3021559140
Location
Dubai
Country
SAUDI ARABIAAddress
Plot No 598-1130 Dip, , Dubai, , Saudi Arabia
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
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
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).
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 |
|---|---|---|---|
| 6/7/2022 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 197COSM COLOR | Division of Northern Border Imports (DNBI) |
| 6/7/2022 | 53BY99OTHER BATH PREPARATIONS, N.E.C. | 197COSM COLOR | Division of Northern Border Imports (DNBI) |
| 6/7/2022 | 53BY99OTHER BATH PREPARATIONS, N.E.C. | 197COSM COLOR | Division of Northern Border Imports (DNBI) |
| 6/7/2022 | 62HBY05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is SMART CHEM HYGEINE's FDA import refusal history?
SMART CHEM HYGEINE (FEI: 3021559140) has 4 FDA import refusal record(s) in our database, spanning from 6/7/2022 to 6/7/2022.
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. SMART CHEM HYGEINE's FEI number is 3021559140.
What types of violations has SMART CHEM HYGEINE received?
SMART CHEM HYGEINE 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 SMART CHEM HYGEINE come from?
All FDA import refusal data for SMART CHEM HYGEINE 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.