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SHANGHAI FUTURESON ELECTRONIC CO

Low Risk

FEI: 3017406239 • Shanghai • CHINA

FEI

FEI Number

3017406239

📍

Location

Shanghai

🇨🇳

Country

CHINA
🏢

Address

Unit 101, 1st Floor, 8, , Shanghai, , China

Low Risk

FDA Import Risk Assessment

20.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
3
Unique Violations
11/10/2020
Latest Refusal
11/10/2020
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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.

3331×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

Refusal History

DateProductViolationsDivision
11/10/2020
77EWOAUDIOMETER
118NOT LISTED
3280FRNMFGREG
333LACKS FIRM
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SHANGHAI FUTURESON ELECTRONIC CO's FDA import refusal history?

SHANGHAI FUTURESON ELECTRONIC CO (FEI: 3017406239) has 1 FDA import refusal record(s) in our database, spanning from 11/10/2020 to 11/10/2020.

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. SHANGHAI FUTURESON ELECTRONIC CO's FEI number is 3017406239.

What types of violations has SHANGHAI FUTURESON ELECTRONIC CO received?

SHANGHAI FUTURESON ELECTRONIC CO 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 SHANGHAI FUTURESON ELECTRONIC CO come from?

All FDA import refusal data for SHANGHAI FUTURESON ELECTRONIC CO 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.