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LUCKY BOARD SAFETY PRODUCTS CO

⚠️ Moderate Risk

FEI: 3016757737 • Shenzhen • CHINA

FEI

FEI Number

3016757737

📍

Location

Shenzhen

🇨🇳

Country

CHINA
🏢

Address

No 34 Pingdi Section, S, , Shenzhen, , China

Moderate Risk

FDA Import Risk Assessment

27.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
7/27/2020
Latest Refusal
7/27/2020
Earliest Refusal

Score Breakdown

Violation Severity
56.7×40%
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.

4791×

DV QUALITY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.

Refusal History

DateProductViolationsDivision
7/27/2020
80ONTN95 RESPIRATOR WITH ANTIMICROBIAL/ANTIVIRAL AGENT
118NOT LISTED
3280FRNMFGREG
479DV QUALITY
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is LUCKY BOARD SAFETY PRODUCTS CO's FDA import refusal history?

LUCKY BOARD SAFETY PRODUCTS CO (FEI: 3016757737) has 1 FDA import refusal record(s) in our database, spanning from 7/27/2020 to 7/27/2020.

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. LUCKY BOARD SAFETY PRODUCTS CO's FEI number is 3016757737.

What types of violations has LUCKY BOARD SAFETY PRODUCTS CO received?

LUCKY BOARD SAFETY PRODUCTS 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 LUCKY BOARD SAFETY PRODUCTS CO come from?

All FDA import refusal data for LUCKY BOARD SAFETY PRODUCTS 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.