Sumitomo Warehouse (Hk) Ltd

⚠️ Moderate Risk

FEI: 3003825378 • Kwai Chung Container Terminal Kwai Chung • HONG KONG

FEI

FEI Number

3003825378

📍

Location

Kwai Chung Container Terminal Kwai Chung

🇭🇰

Country

HONG KONG

🏢

Address

Rm 13012 13/F. Asia Terminal B Berth 3, , Kwai Chung Container Terminal Kwai Chung, , Hong Kong

Moderate Risk

FDA Import Risk Assessment

33.6

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

8/24/2004

Latest Refusal

12/15/2003

Earliest Refusal

Score Breakdown

Violation Severity

50.0×40%

Refusal Volume

28.8×30%

Recency

0.0×20%

Frequency

50.0×10%

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

Violation Summary

3415×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

5085×

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.

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).

Refusal History

Date	Product	Violations	Division
8/24/2004	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	118NOT LISTED 341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
3/22/2004	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	118NOT LISTED 341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
2/19/2004	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	118NOT LISTED 341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
1/23/2004	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	118NOT LISTED 341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
12/15/2003	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)

Frequently Asked Questions

What is Sumitomo Warehouse (Hk) Ltd's FDA import refusal history?

Sumitomo Warehouse (Hk) Ltd (FEI: 3003825378) has 5 FDA import refusal record(s) in our database, spanning from 12/15/2003 to 8/24/2004.

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. Sumitomo Warehouse (Hk) Ltd's FEI number is 3003825378.

What types of violations has Sumitomo Warehouse (Hk) Ltd received?

Sumitomo Warehouse (Hk) Ltd 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 Sumitomo Warehouse (Hk) Ltd come from?

All FDA import refusal data for Sumitomo Warehouse (Hk) 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.