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CACUN BRD OPTICAL CO LTD

Low Risk

FEI: 3014741746 • Tongzhou • CHINA

FEI

FEI Number

3014741746

📍

Location

Tongzhou

🇨🇳

Country

CHINA
🏢

Address

Fucheng Square Yanjiao, , Tongzhou, , China

Low Risk

FDA Import Risk Assessment

22.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
2/7/2019
Latest Refusal
2/7/2019
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
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).

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

Refusal History

DateProductViolationsDivision
2/7/2019
80FMQRESTRAINT, PROTECTIVE
118NOT LISTED
473LABELING
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is CACUN BRD OPTICAL CO LTD's FDA import refusal history?

CACUN BRD OPTICAL CO LTD (FEI: 3014741746) has 1 FDA import refusal record(s) in our database, spanning from 2/7/2019 to 2/7/2019.

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. CACUN BRD OPTICAL CO LTD's FEI number is 3014741746.

What types of violations has CACUN BRD OPTICAL CO LTD received?

CACUN BRD OPTICAL CO LTD 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 CACUN BRD OPTICAL CO LTD come from?

All FDA import refusal data for CACUN BRD OPTICAL CO LTD 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.