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SMART CHEM HYGIENE LLC

⚠️ Moderate Risk

FEI: 3021650740 • Dubai • UNITED ARAB EMIRATES

FEI

FEI Number

3021650740

📍

Location

Dubai

🇦🇪
🏢

Address

Dubai Investment Park 1, Street Number 74 Warehouse Number 2, Dubai, , United Arab Emirates

Moderate Risk

FDA Import Risk Assessment

28.1
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
2
Unique Violations
9/6/2022
Latest Refusal
9/6/2022
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
19.0×20%
Frequency
10.0×10%
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

1181×

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).

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
9/6/2022
62HBK05ETHYL ALCOHOL (ANTI-MICROBIAL)
118NOT LISTED
3280FRNMFGREG
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is SMART CHEM HYGIENE LLC's FDA import refusal history?

SMART CHEM HYGIENE LLC (FEI: 3021650740) has 1 FDA import refusal record(s) in our database, spanning from 9/6/2022 to 9/6/2022.

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 HYGIENE LLC's FEI number is 3021650740.

What types of violations has SMART CHEM HYGIENE LLC received?

SMART CHEM HYGIENE LLC 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 SMART CHEM HYGIENE LLC come from?

All FDA import refusal data for SMART CHEM HYGIENE LLC 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.