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Tee Vee Brands International Ltd.

⚠️ Moderate Risk

FEI: 3007842069 • Hung Hom, Kowloon • HONG KONG

FEI

FEI Number

3007842069

📍

Location

Hung Hom, Kowloon

🇭🇰

Country

HONG KONG
🏢

Address

Suite 1210c, 12/F, Harbour Centre Tower1; 1 Hok Cheung Street, Hung Hom, Kowloon, Hong Kong

Moderate Risk

FDA Import Risk Assessment

38.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
10/28/2009
Latest Refusal
10/28/2009
Earliest Refusal

Score Breakdown

Violation Severity
85.0×40%
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

2371×

NO PMA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).

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
10/28/2009
80MSNCIGARETTES (CONTAINING TOBACCO)
237NO PMA
75UNAPPROVED
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Tee Vee Brands International Ltd.'s FDA import refusal history?

Tee Vee Brands International Ltd. (FEI: 3007842069) has 1 FDA import refusal record(s) in our database, spanning from 10/28/2009 to 10/28/2009.

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. Tee Vee Brands International Ltd.'s FEI number is 3007842069.

What types of violations has Tee Vee Brands International Ltd. received?

Tee Vee Brands International 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 Tee Vee Brands International Ltd. come from?

All FDA import refusal data for Tee Vee Brands International 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.