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Tai Loy Cosmetic Co.Ltd (Hk)

⚠️ Moderate Risk

FEI: 3004600958 • Hong Kong • HONG KONG

FEI

FEI Number

3004600958

📍

Location

Hong Kong

🇭🇰

Country

HONG KONG
🏢

Address

58-76 Ta Chuen Ping Street, Unit 5a-5b, G, Hong Kong, , Hong Kong

Moderate Risk

FDA Import Risk Assessment

39.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
5/6/2010
Latest Refusal
5/6/2010
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

162×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

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).

Refusal History

DateProductViolationsDivision
5/6/2010
66VKY99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
75UNAPPROVED
San Francisco District Office (SAN-DO)
5/6/2010
66VKY99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
75UNAPPROVED
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Tai Loy Cosmetic Co.Ltd (Hk)'s FDA import refusal history?

Tai Loy Cosmetic Co.Ltd (Hk) (FEI: 3004600958) has 2 FDA import refusal record(s) in our database, spanning from 5/6/2010 to 5/6/2010.

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. Tai Loy Cosmetic Co.Ltd (Hk)'s FEI number is 3004600958.

What types of violations has Tai Loy Cosmetic Co.Ltd (Hk) received?

Tai Loy Cosmetic Co.Ltd (Hk) 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 Tai Loy Cosmetic Co.Ltd (Hk) come from?

All FDA import refusal data for Tai Loy Cosmetic Co.Ltd (Hk) 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.