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OWL SUPPLY CHAIN (HK)LIMITED

⚠️ Moderate Risk

FEI: 3026548582 • To Kwa Wan • HONG KONG

FEI

FEI Number

3026548582

📍

Location

To Kwa Wan

🇭🇰

Country

HONG KONG
🏢

Address

Unit A911, 9/F, Acro Industarial Buil; Ding 19 Yuk Yat St, To Kwa Wan, , Hong Kong

Moderate Risk

FDA Import Risk Assessment

33.8
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
6/5/2023
Latest Refusal
6/5/2023
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
47.3×20%
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

1181×

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).

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
6/5/2023
76LRKDEVICE, ANTI-SNORING
118NOT LISTED
3280FRNMFGREG
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is OWL SUPPLY CHAIN (HK)LIMITED's FDA import refusal history?

OWL SUPPLY CHAIN (HK)LIMITED (FEI: 3026548582) has 1 FDA import refusal record(s) in our database, spanning from 6/5/2023 to 6/5/2023.

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. OWL SUPPLY CHAIN (HK)LIMITED's FEI number is 3026548582.

What types of violations has OWL SUPPLY CHAIN (HK)LIMITED received?

OWL SUPPLY CHAIN (HK)LIMITED 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 OWL SUPPLY CHAIN (HK)LIMITED come from?

All FDA import refusal data for OWL SUPPLY CHAIN (HK)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.