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Kosway Industries Co Ltd

✅ Low Risk

FEI: 3008324215 • Ping Di Longgang, Guangdong • CHINA

FEI

FEI Number

3008324215

📍

Location

Ping Di Longgang, Guangdong

🇨🇳

Country

CHINA
🏢

Address

88 Bao Shek Yee Road, Shek Fiu Wai Central Estate, Ping Di Longgang, Guangdong, 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
2
Unique Violations
3/7/2013
Latest Refusal
3/7/2013
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).

37411×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.

Refusal History

DateProductViolationsDivision
3/7/2013
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
3741FRNMFGREG
Baltimore District Office (BLT-DO)

Frequently Asked Questions

What is Kosway Industries Co Ltd's FDA import refusal history?

Kosway Industries Co Ltd (FEI: 3008324215) has 1 FDA import refusal record(s) in our database, spanning from 3/7/2013 to 3/7/2013.

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. Kosway Industries Co Ltd's FEI number is 3008324215.

What types of violations has Kosway Industries Co Ltd received?

Kosway Industries 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 Kosway Industries Co Ltd come from?

All FDA import refusal data for Kosway Industries 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.