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MEDIATANK HONGKONG CO LTD

⚠️ Moderate Risk

FEI: 3033027978 • Kowloon Bay, Kowloon • HONG KONG

FEI

FEI Number

3033027978

📍

Location

Kowloon Bay, Kowloon

🇭🇰

Country

HONG KONG
🏢

Address

Wing Fat Industrial Building Wealthy Industrial Building, 12 Wang Tai Road, Kowloon Bay, Kowloon, Hong Kong

Moderate Risk

FDA Import Risk Assessment

40.2
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
12/30/2024
Latest Refusal
12/30/2024
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
79.4×20%
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

32601×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)

841×

RX DEVICE

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.

Refusal History

DateProductViolationsDivision
12/30/2024
86QITDAILY WEAR SOFT CONTACT LENS TO REDUCE THE PROGRESSION OF MYOPIA
3260NO ENGLISH
84RX DEVICE
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is MEDIATANK HONGKONG CO LTD's FDA import refusal history?

MEDIATANK HONGKONG CO LTD (FEI: 3033027978) has 1 FDA import refusal record(s) in our database, spanning from 12/30/2024 to 12/30/2024.

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. MEDIATANK HONGKONG CO LTD's FEI number is 3033027978.

What types of violations has MEDIATANK HONGKONG CO LTD received?

MEDIATANK HONGKONG 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 MEDIATANK HONGKONG CO LTD come from?

All FDA import refusal data for MEDIATANK HONGKONG 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.