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Moyan Industry (China) Ltd

⚠️ Moderate Risk

FEI: 3010954982 • Kowloon • HONG KONG

FEI

FEI Number

3010954982

📍

Location

Kowloon

🇭🇰

Country

HONG KONG
🏢

Address

2 Lei Yue Mun Road, Rm 517, New City Center, Kwun Tong, Kowloon, , Hong Kong

Moderate Risk

FDA Import Risk Assessment

29.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
9/2/2014
Latest Refusal
9/2/2014
Earliest Refusal

Score Breakdown

Violation Severity
63.3×40%
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).

4831×

DRUG NAME

The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
9/2/2014
66YIY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
483DRUG NAME
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Moyan Industry (China) Ltd's FDA import refusal history?

Moyan Industry (China) Ltd (FEI: 3010954982) has 1 FDA import refusal record(s) in our database, spanning from 9/2/2014 to 9/2/2014.

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. Moyan Industry (China) Ltd's FEI number is 3010954982.

What types of violations has Moyan Industry (China) Ltd received?

Moyan Industry (China) Ltd 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 Moyan Industry (China) Ltd come from?

All FDA import refusal data for Moyan Industry (China) 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.