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Infinity Nova Trading Limited

⚠️ Moderate Risk

FEI: 3010139033 • Tsim Sha Tsui, Kowloon • HONG KONG

FEI

FEI Number

3010139033

📍

Location

Tsim Sha Tsui, Kowloon

🇭🇰

Country

HONG KONG
🏢

Address

Unit 5, 5/F Canton Road, Tsim Sha Tsui, Kowloon, Hong Kong

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
5/18/2015
Latest Refusal
5/18/2015
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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).

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
5/18/2015
65FDS03WATER, FOR INJECTION, U.S.P. (PHARMACEUTIC AID)
118NOT LISTED
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Infinity Nova Trading Limited's FDA import refusal history?

Infinity Nova Trading Limited (FEI: 3010139033) has 1 FDA import refusal record(s) in our database, spanning from 5/18/2015 to 5/18/2015.

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. Infinity Nova Trading Limited's FEI number is 3010139033.

What types of violations has Infinity Nova Trading Limited received?

Infinity Nova Trading Limited 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 Infinity Nova Trading Limited come from?

All FDA import refusal data for Infinity Nova Trading Limited 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.