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Aglaia Healthcare Co., Limited

⚠️ Moderate Risk

FEI: 3009318015 • Hong Kong • HONG KONG

FEI

FEI Number

3009318015

📍

Location

Hong Kong

🇭🇰

Country

HONG KONG
🏢

Address

Rm 907 Jnb1113,Wing Tuck Comm, , Hong Kong, , Hong Kong

Moderate Risk

FDA Import Risk Assessment

29.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
2/16/2012
Latest Refusal
2/16/2012
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

1183×

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).

Refusal History

DateProductViolationsDivision
2/16/2012
74OEDANTIMICROBIAL BLOOD PRESSURE CUFF
118NOT LISTED
Division of Southeast Imports (DSEI)
2/16/2012
74OEDANTIMICROBIAL BLOOD PRESSURE CUFF
118NOT LISTED
Division of Southeast Imports (DSEI)
2/16/2012
74OEDANTIMICROBIAL BLOOD PRESSURE CUFF
118NOT LISTED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Aglaia Healthcare Co., Limited's FDA import refusal history?

Aglaia Healthcare Co., Limited (FEI: 3009318015) has 3 FDA import refusal record(s) in our database, spanning from 2/16/2012 to 2/16/2012.

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. Aglaia Healthcare Co., Limited's FEI number is 3009318015.

What types of violations has Aglaia Healthcare Co., Limited received?

Aglaia Healthcare Co., Limited has been cited for 1 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 Aglaia Healthcare Co., Limited come from?

All FDA import refusal data for Aglaia Healthcare Co., Limited 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.