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LOVEHONEY JM SUNFLOWER

⚠️ Moderate Risk

FEI: 3012381496 • FABRICO FACTORY • HONG KONG

FEI

FEI Number

3012381496

📍

Location

FABRICO FACTORY

🇭🇰

Country

HONG KONG
🏢

Address

JM SUNFLOWER LTD UNIT 3, , FABRICO FACTORY, , Hong Kong

Moderate Risk

FDA Import Risk Assessment

34.5
LowModerateHighCritical

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

Statistics

3
Total Refusals
3
Unique Violations
3/16/2017
Latest Refusal
8/3/2016
Earliest Refusal

Score Breakdown

Violation Severity
62.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

163×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

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
3/16/2017
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
16DIRECTIONS
New Orleans District Office (NOL-DO)
8/3/2016
78LKYDEVICE, EXTERNAL PENILE RIGIDITY
118NOT LISTED
16DIRECTIONS
3280FRNMFGREG
Division of Southeast Imports (DSEI)
8/3/2016
78LKYDEVICE, EXTERNAL PENILE RIGIDITY
16DIRECTIONS
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is LOVEHONEY JM SUNFLOWER's FDA import refusal history?

LOVEHONEY JM SUNFLOWER (FEI: 3012381496) has 3 FDA import refusal record(s) in our database, spanning from 8/3/2016 to 3/16/2017.

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. LOVEHONEY JM SUNFLOWER's FEI number is 3012381496.

What types of violations has LOVEHONEY JM SUNFLOWER received?

LOVEHONEY JM SUNFLOWER 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 LOVEHONEY JM SUNFLOWER come from?

All FDA import refusal data for LOVEHONEY JM SUNFLOWER 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.