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Asia Pacific Beauty

⚠️ Moderate Risk

FEI: 3004143935 • Kowloon • HONG KONG

FEI

FEI Number

3004143935

📍

Location

Kowloon

🇭🇰

Country

HONG KONG
🏢

Address

23 Hankow Road, , Kowloon, , Hong Kong

Moderate Risk

FDA Import Risk Assessment

31.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
1/25/2006
Latest Refusal
1/25/2006
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

1182×

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).

4762×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

5082×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
1/25/2006
84LLPLASER FOR PAIN THERAPY
118NOT LISTED
476NO REGISTR
508NO 510(K)
New York District Office (NYK-DO)
1/25/2006
89ILYLAMP, INFRARED, THERAPEUTIC HEATING
118NOT LISTED
476NO REGISTR
508NO 510(K)
New York District Office (NYK-DO)

Frequently Asked Questions

What is Asia Pacific Beauty's FDA import refusal history?

Asia Pacific Beauty (FEI: 3004143935) has 2 FDA import refusal record(s) in our database, spanning from 1/25/2006 to 1/25/2006.

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. Asia Pacific Beauty's FEI number is 3004143935.

What types of violations has Asia Pacific Beauty received?

Asia Pacific Beauty has been cited for 3 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 Asia Pacific Beauty come from?

All FDA import refusal data for Asia Pacific Beauty 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.