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SHENZHEN BOFENG INTERNATIONAL LOGIS

⚠️ Moderate Risk

FEI: 3013857139 • Shanghai, Shanghai • CHINA

FEI

FEI Number

3013857139

📍

Location

Shanghai, Shanghai

🇨🇳

Country

CHINA
🏢

Address

No. 888 Lane 1295 Huazhird Qingpu, , Shanghai, Shanghai, China

Moderate Risk

FDA Import Risk Assessment

26.4
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
12/2/2021
Latest Refusal
12/2/2021
Earliest Refusal

Score Breakdown

Violation Severity
53.3×40%
Refusal Volume
11.2×30%
Recency
3.8×20%
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).

2351×

NOT IMPACT

The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.

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
12/2/2021
86HOISPECTACLE, MAGNIFYING
118NOT LISTED
235NOT IMPACT
3280FRNMFGREG
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SHENZHEN BOFENG INTERNATIONAL LOGIS's FDA import refusal history?

SHENZHEN BOFENG INTERNATIONAL LOGIS (FEI: 3013857139) has 1 FDA import refusal record(s) in our database, spanning from 12/2/2021 to 12/2/2021.

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. SHENZHEN BOFENG INTERNATIONAL LOGIS's FEI number is 3013857139.

What types of violations has SHENZHEN BOFENG INTERNATIONAL LOGIS received?

SHENZHEN BOFENG INTERNATIONAL LOGIS 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 SHENZHEN BOFENG INTERNATIONAL LOGIS come from?

All FDA import refusal data for SHENZHEN BOFENG INTERNATIONAL LOGIS 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.