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KEYWAY TECH DEVELOPMENT CO LTD

⚠️ Moderate Risk

FEI: 3013520350 • GUANGDONG • CHINA

FEI

FEI Number

3013520350

📍

Location

GUANGDONG

🇨🇳

Country

CHINA
🏢

Address

2421 NANGUANGJIEJIA BLD, , GUANGDONG, , China

Moderate Risk

FDA Import Risk Assessment

30.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
6/6/2017
Latest Refusal
6/6/2017
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
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).

1261×

FAILS STD

The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.

Refusal History

DateProductViolationsDivision
6/6/2017
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
126FAILS STD
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is KEYWAY TECH DEVELOPMENT CO LTD's FDA import refusal history?

KEYWAY TECH DEVELOPMENT CO LTD (FEI: 3013520350) has 1 FDA import refusal record(s) in our database, spanning from 6/6/2017 to 6/6/2017.

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. KEYWAY TECH DEVELOPMENT CO LTD's FEI number is 3013520350.

What types of violations has KEYWAY TECH DEVELOPMENT CO LTD received?

KEYWAY TECH DEVELOPMENT 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 KEYWAY TECH DEVELOPMENT CO LTD come from?

All FDA import refusal data for KEYWAY TECH DEVELOPMENT 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.