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Gui Nan Hong Company Limited

⚠️ High Risk

FEI: 3017744637 • Sheung Wan • HONG KONG

FEI

FEI Number

3017744637

📍

Location

Sheung Wan

🇭🇰

Country

HONG KONG
🏢

Address

G/F 98 Des Voeux Rd West, , Sheung Wan, , Hong Kong

High Risk

FDA Import Risk Assessment

73.3
LowModerateHighCritical

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

Statistics

22
Total Refusals
14
Unique Violations
11/6/2025
Latest Refusal
3/9/2022
Earliest Refusal

Score Breakdown

Violation Severity
82.2×40%
Refusal Volume
50.4×30%
Recency
96.5×20%
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

2497×

FILTHY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.

2414×

PESTICIDE

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a pesticide chemical residue, which causes the article to be adulterated within the meaning of section 402(a)(2)(B) of the FD&C Act. Bears or contains:

20403×

SULFITELBL

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded because 1) it appears to contain sulfites but the label fails to declare the presence of sulfites, a fact material to sulfite-sensitive individuals who must avoid the ingredient due to potential health consequences from its consumption, and 2) it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient.

34002×

PB-FOOD

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a poisonous or deleterious substance, lead, which may render it injurious to health.

2512×

POISONOUS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:

3411×

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).

4821×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

5081×

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.

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).

91×

SALMONELLA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Salmonella, a poisonous and deleterious substance which may render it injurious to health.

2181×

LIST INGRE

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(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

2381×

UNSAFE ADD

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.

2601×

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.

28601×

VETDRUGRES

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a new animal drug (or conversion product thereof) that is unsafe within the meaning of Section 512. Product contains

Refusal History

DateProductViolationsDivision
11/6/2025
21BYH09OTHER FRUITS, MIXED, DRIED OR PASTE
2040SULFITELBL
Division of West Coast Imports (DWCI)
11/6/2025
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
2040SULFITELBL
Division of West Coast Imports (DWCI)
9/15/2025
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
2040SULFITELBL
Division of Northeast Imports (DNEI)
9/5/2025
21BYH09OTHER FRUITS, MIXED, DRIED OR PASTE
9SALMONELLA
Division of Northeast Imports (DNEI)
5/7/2025
16JYH05SHRIMP & PRAWNS
238UNSAFE ADD
2860VETDRUGRES
Division of West Coast Imports (DWCI)
5/6/2025
25SYH04MUSHROOM, SHIITAKE, FUNGI PRODUCTS, N.E.C.
249FILTHY
Division of Northeast Imports (DNEI)
12/26/2024
76EFWTOOTHBRUSH, MANUAL
118NOT LISTED
341REGISTERED
508NO 510(K)
Division of West Coast Imports (DWCI)
3/6/2024
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
251POISONOUS
Division of Northeast Imports (DNEI)
2/22/2024
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
218LIST INGRE
260FALSE
482NUTRIT LBL
Division of Northeast Imports (DNEI)
12/4/2023
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
249FILTHY
Division of Northeast Imports (DNEI)
5/24/2023
21HYH05DATES, DRIED OR PASTE
249FILTHY
Division of Northeast Imports (DNEI)
11/21/2022
21TYH03FIG, DRIED OR PASTE
241PESTICIDE
Division of West Coast Imports (DWCI)
11/17/2022
21TYH03FIG, DRIED OR PASTE
241PESTICIDE
Division of West Coast Imports (DWCI)
11/9/2022
21TYH03FIG, DRIED OR PASTE
241PESTICIDE
Division of West Coast Imports (DWCI)
11/3/2022
21TYH03FIG, DRIED OR PASTE
241PESTICIDE
Division of West Coast Imports (DWCI)
10/28/2022
25QYH99MUSHROOMS AND OTHER FUNGI PRODUCTS, PIECES AND STEMS, SLICED, N.E.C.
249FILTHY
Division of Northeast Imports (DNEI)
8/9/2022
21HYH14PLUM, DRIED OR PASTE
3400PB-FOOD
Division of Northeast Imports (DNEI)
7/22/2022
21HYH14PLUM, DRIED OR PASTE
3400PB-FOOD
Division of Northeast Imports (DNEI)
7/22/2022
21GYH16CHINESE RED DATE (JUJUBES, ZIZIPHUS JUJUBA) (PIT FRUIT)
249FILTHY
Division of Northeast Imports (DNEI)
6/7/2022
21HYH14PLUM, DRIED OR PASTE
251POISONOUS
Division of Northeast Imports (DNEI)
6/7/2022
21GYH16CHINESE RED DATE (JUJUBES, ZIZIPHUS JUJUBA) (PIT FRUIT)
249FILTHY
Division of Northeast Imports (DNEI)
3/9/2022
25QYH99MUSHROOMS AND OTHER FUNGI PRODUCTS, PIECES AND STEMS, SLICED, N.E.C.
249FILTHY
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Gui Nan Hong Company Limited's FDA import refusal history?

Gui Nan Hong Company Limited (FEI: 3017744637) has 22 FDA import refusal record(s) in our database, spanning from 3/9/2022 to 11/6/2025.

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. Gui Nan Hong Company Limited's FEI number is 3017744637.

What types of violations has Gui Nan Hong Company Limited received?

Gui Nan Hong Company Limited has been cited for 14 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 Gui Nan Hong Company Limited come from?

All FDA import refusal data for Gui Nan Hong Company 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.