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Hongkong Silkroad International Gro

⚠️ Moderate Risk

FEI: 3007816427 • Fuxinshi, Liaoning • CHINA

FEI

FEI Number

3007816427

📍

Location

Fuxinshi, Liaoning

🇨🇳

Country

CHINA
🏢

Address

Room 605 No21580 Nong Siping Road, , Fuxinshi, Liaoning, China

Moderate Risk

FDA Import Risk Assessment

42.5
LowModerateHighCritical

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

Statistics

5
Total Refusals
2
Unique Violations
12/11/2009
Latest Refusal
10/16/2009
Earliest Refusal

Score Breakdown

Violation Severity
72.2×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

755×

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).

1184×

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).

Refusal History

DateProductViolationsDivision
12/11/2009
66BAL44NICOTINE DELIVERY SYSTEM
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)
12/11/2009
66BAS44NICOTINE DELIVERY SYSTEM
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)
12/11/2009
66BAS44NICOTINE DELIVERY SYSTEM
75UNAPPROVED
Los Angeles District Office (LOS-DO)
10/16/2009
66BAS44NICOTINE DELIVERY SYSTEM
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)
10/16/2009
66BAS44NICOTINE DELIVERY SYSTEM
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Hongkong Silkroad International Gro's FDA import refusal history?

Hongkong Silkroad International Gro (FEI: 3007816427) has 5 FDA import refusal record(s) in our database, spanning from 10/16/2009 to 12/11/2009.

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. Hongkong Silkroad International Gro's FEI number is 3007816427.

What types of violations has Hongkong Silkroad International Gro received?

Hongkong Silkroad International Gro 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 Hongkong Silkroad International Gro come from?

All FDA import refusal data for Hongkong Silkroad International Gro 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.