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Open Fortune Community Hk Ltd

⚠️ Moderate Risk

FEI: 3004521581 • Kowloon • HONG KONG

FEI

FEI Number

3004521581

📍

Location

Kowloon

🇭🇰

Country

HONG KONG
🏢

Address

Rm 1001-1009 10/F Grand Century Place, 193 Prince Edward Road West, Kowloon, , Hong Kong

Moderate Risk

FDA Import Risk Assessment

30.4
LowModerateHighCritical

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

Statistics

6
Total Refusals
4
Unique Violations
5/27/2004
Latest Refusal
5/27/2004
Earliest Refusal

Score Breakdown

Violation Severity
37.5×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
60.0×10%
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

2606×

FALSE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.

3206×

LACKS FIRM

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.

3246×

NO ENGLISH

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).

4736×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

Refusal History

DateProductViolationsDivision
5/27/2004
54YCA99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
260FALSE
320LACKS FIRM
324NO ENGLISH
473LABELING
Detroit District Office (DET-DO)
5/27/2004
54YCA99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
260FALSE
320LACKS FIRM
324NO ENGLISH
473LABELING
Detroit District Office (DET-DO)
5/27/2004
54YCB99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
260FALSE
320LACKS FIRM
324NO ENGLISH
473LABELING
Detroit District Office (DET-DO)
5/27/2004
54YCB99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
260FALSE
320LACKS FIRM
324NO ENGLISH
473LABELING
Detroit District Office (DET-DO)
5/27/2004
54YCB99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
260FALSE
320LACKS FIRM
324NO ENGLISH
473LABELING
Detroit District Office (DET-DO)
5/27/2004
54YCB99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
260FALSE
320LACKS FIRM
324NO ENGLISH
473LABELING
Detroit District Office (DET-DO)

Frequently Asked Questions

What is Open Fortune Community Hk Ltd's FDA import refusal history?

Open Fortune Community Hk Ltd (FEI: 3004521581) has 6 FDA import refusal record(s) in our database, spanning from 5/27/2004 to 5/27/2004.

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. Open Fortune Community Hk Ltd's FEI number is 3004521581.

What types of violations has Open Fortune Community Hk Ltd received?

Open Fortune Community Hk Ltd has been cited for 4 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 Open Fortune Community Hk Ltd come from?

All FDA import refusal data for Open Fortune Community 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.