ImportRefusal LogoImportRefusal

Million Way Investiments Ltd

⚠️ Moderate Risk

FEI: 3007634785 • Sai Ying Pun, Hong Kong Island • HONG KONG

FEI

FEI Number

3007634785

📍

Location

Sai Ying Pun, Hong Kong Island

🇭🇰

Country

HONG KONG
🏢

Address

1/F, Qualipak Tower; 122 Connaught Road West, Sai Ying Pun, Hong Kong Island, Hong Kong

Moderate Risk

FDA Import Risk Assessment

35.3
LowModerateHighCritical

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

Statistics

4
Total Refusals
4
Unique Violations
9/29/2010
Latest Refusal
6/24/2010
Earliest Refusal

Score Breakdown

Violation Severity
58.8×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

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).

752×

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).

2601×

FALSE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.

29401×

COSM MISB

The cosmetic's labeling appears to be false or misleading within the meaning of Section 201(n).

Refusal History

DateProductViolationsDivision
9/29/2010
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
118NOT LISTED
2940COSM MISB
75UNAPPROVED
Los Angeles District Office (LOS-DO)
9/29/2010
53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
118NOT LISTED
260FALSE
75UNAPPROVED
Los Angeles District Office (LOS-DO)
9/29/2010
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
118NOT LISTED
Los Angeles District Office (LOS-DO)
6/24/2010
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
118NOT LISTED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Million Way Investiments Ltd's FDA import refusal history?

Million Way Investiments Ltd (FEI: 3007634785) has 4 FDA import refusal record(s) in our database, spanning from 6/24/2010 to 9/29/2010.

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. Million Way Investiments Ltd's FEI number is 3007634785.

What types of violations has Million Way Investiments Ltd received?

Million Way Investiments Ltd has been cited for 4 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 Million Way Investiments Ltd come from?

All FDA import refusal data for Million Way Investiments 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.