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Zegna-Daidong Limited

⚠️ High Risk

FEI: 3002580724 • Kowloon Bay, Kowloon • HONG KONG

FEI

FEI Number

3002580724

📍

Location

Kowloon Bay, Kowloon

🇭🇰

Country

HONG KONG
🏢

Address

Nam Fung Commercial Centre, 19 Lam Lok Street, Kowloon Bay, Kowloon, Hong Kong

High Risk

FDA Import Risk Assessment

62.6
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

94
Total Refusals
3
Unique Violations
1/18/2023
Latest Refusal
10/7/2005
Earliest Refusal

Score Breakdown

Violation Severity
67.8×40%
Refusal Volume
73.3×30%
Recency
40.4×20%
Frequency
54.4×10%
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

4772×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

47621×

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).

27801×

DEVICEGMPS

The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.

Refusal History

DateProductViolationsDivision
1/18/2023
95RFVCD, CD-ROM PLAYER, LASER UTILITY/PERIPHERAL LASER PRODUCTS
2780DEVICEGMPS
Division of Southeast Imports (DSEI)
6/22/2010
95RFVCD, CD-ROM PLAYER, LASER UTILITY/PERIPHERAL LASER PRODUCTS
47NON STD
Division of Southeast Imports (DSEI)
6/22/2010
95RFVCD, CD-ROM PLAYER, LASER UTILITY/PERIPHERAL LASER PRODUCTS
47NON STD
Division of Southeast Imports (DSEI)
6/22/2010
95RFVCD, CD-ROM PLAYER, LASER UTILITY/PERIPHERAL LASER PRODUCTS
47NON STD
Division of Southeast Imports (DSEI)
6/22/2010
95RFVCD, CD-ROM PLAYER, LASER UTILITY/PERIPHERAL LASER PRODUCTS
47NON STD
Division of Southeast Imports (DSEI)
6/22/2010
95RFVCD, CD-ROM PLAYER, LASER UTILITY/PERIPHERAL LASER PRODUCTS
47NON STD
Division of Southeast Imports (DSEI)
6/22/2010
95RFVCD, CD-ROM PLAYER, LASER UTILITY/PERIPHERAL LASER PRODUCTS
47NON STD
Division of Southeast Imports (DSEI)
8/25/2008
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
8/25/2008
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
8/25/2008
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
8/25/2008
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
8/25/2008
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
5/23/2008
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
5/6/2008
95L31CD PLAYERS (COMPACT DISC PLAYERS)
476NO REGISTR
Division of Southeast Imports (DSEI)
5/6/2008
95L31CD PLAYERS (COMPACT DISC PLAYERS)
476NO REGISTR
Division of Southeast Imports (DSEI)
4/25/2008
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
4/8/2008
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
4/4/2008
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
4/4/2008
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
4/4/2008
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
4/4/2008
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
3/28/2008
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
2/15/2008
95L31CD PLAYERS (COMPACT DISC PLAYERS)
476NO REGISTR
Division of Southeast Imports (DSEI)
2/15/2008
95L31CD PLAYERS (COMPACT DISC PLAYERS)
476NO REGISTR
Division of Southeast Imports (DSEI)
1/18/2008
95L31CD PLAYERS (COMPACT DISC PLAYERS)
476NO REGISTR
Division of Southeast Imports (DSEI)
1/18/2008
95L31CD PLAYERS (COMPACT DISC PLAYERS)
476NO REGISTR
Division of Southeast Imports (DSEI)
12/20/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
12/11/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
12/11/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
11/19/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
476NO REGISTR
Division of Southeast Imports (DSEI)
11/8/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
11/8/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
11/8/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
11/8/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
11/6/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
11/6/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
11/6/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
11/6/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
10/30/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
10/19/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
10/19/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
10/19/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
10/19/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
10/19/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
10/19/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
10/19/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
10/15/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
10/15/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
10/1/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
476NO REGISTR
Division of Southeast Imports (DSEI)
9/25/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
9/25/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
9/21/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
476NO REGISTR
Division of Southeast Imports (DSEI)
9/21/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
476NO REGISTR
Division of Southeast Imports (DSEI)
9/21/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
476NO REGISTR
Division of Southeast Imports (DSEI)
9/21/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
476NO REGISTR
Division of Southeast Imports (DSEI)
9/21/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
476NO REGISTR
Division of Southeast Imports (DSEI)
8/3/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
7/31/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
7/31/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
7/31/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
7/31/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
7/25/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
7/13/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
5/31/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
476NO REGISTR
Division of Southeast Imports (DSEI)
5/31/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
476NO REGISTR
Division of Southeast Imports (DSEI)
5/31/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
476NO REGISTR
Division of Southeast Imports (DSEI)
5/31/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
476NO REGISTR
Division of Southeast Imports (DSEI)
5/29/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
5/29/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
5/29/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
5/22/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
5/22/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
5/22/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
5/22/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
5/22/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
5/22/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Florida District Office (FLA-DO)
5/22/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Florida District Office (FLA-DO)
5/22/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Florida District Office (FLA-DO)
5/22/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Florida District Office (FLA-DO)
5/22/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Florida District Office (FLA-DO)
5/10/2007
95L31CD PLAYERS (COMPACT DISC PLAYERS)
47NON STD
Division of Southeast Imports (DSEI)
11/3/2006
95L32CD PLAYER COMBINATION SYSTEMS
47NON STD
Florida District Office (FLA-DO)
10/24/2006
95L32CD PLAYER COMBINATION SYSTEMS
476NO REGISTR
Florida District Office (FLA-DO)
10/24/2006
95L32CD PLAYER COMBINATION SYSTEMS
476NO REGISTR
Florida District Office (FLA-DO)
10/20/2006
95L32CD PLAYER COMBINATION SYSTEMS
476NO REGISTR
Florida District Office (FLA-DO)
9/21/2006
95L32CD PLAYER COMBINATION SYSTEMS
476NO REGISTR
Division of Southeast Imports (DSEI)
9/20/2006
95L32CD PLAYER COMBINATION SYSTEMS
47NON STD
Division of Southeast Imports (DSEI)
9/18/2006
95L32CD PLAYER COMBINATION SYSTEMS
47NON STD
Florida District Office (FLA-DO)
9/18/2006
95L32CD PLAYER COMBINATION SYSTEMS
47NON STD
Florida District Office (FLA-DO)
8/24/2006
95L32CD PLAYER COMBINATION SYSTEMS
47NON STD
Florida District Office (FLA-DO)
8/24/2006
95L32CD PLAYER COMBINATION SYSTEMS
47NON STD
Florida District Office (FLA-DO)
8/24/2006
95L32CD PLAYER COMBINATION SYSTEMS
47NON STD
Florida District Office (FLA-DO)
6/26/2006
95L32CD PLAYER COMBINATION SYSTEMS
47NON STD
Florida District Office (FLA-DO)
10/7/2005
95L32CD PLAYER COMBINATION SYSTEMS
47NON STD
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Zegna-Daidong Limited's FDA import refusal history?

Zegna-Daidong Limited (FEI: 3002580724) has 94 FDA import refusal record(s) in our database, spanning from 10/7/2005 to 1/18/2023.

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. Zegna-Daidong Limited's FEI number is 3002580724.

What types of violations has Zegna-Daidong Limited received?

Zegna-Daidong Limited 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 Zegna-Daidong Limited come from?

All FDA import refusal data for Zegna-Daidong 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.