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Zhuhai City Tonghui Pharmaceutical Co.,Ltd.

⚠️ High Risk

FEI: 3007512797 • Zhuhai, Guangdong • CHINA

FEI

FEI Number

3007512797

📍

Location

Zhuhai, Guangdong

🇨🇳

Country

CHINA
🏢

Address

Longshan Industrial, No. 10 Chisan Road; Doumen Town, Zhuhai, Guangdong, China

High Risk

FDA Import Risk Assessment

54.9
LowModerateHighCritical

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

Statistics

29
Total Refusals
16
Unique Violations
4/28/2022
Latest Refusal
10/20/2009
Earliest Refusal

Score Breakdown

Violation Severity
77.5×40%
Refusal Volume
54.7×30%
Recency
25.8×20%
Frequency
23.1×10%
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.

4826×

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.

31203×

EPHEDALK

The product is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a dietary supplement or a dietary ingredient that appears to contain ephedrine alkaloids, which presents an unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling, or if no conditions of use are suggested in the labeling, under ordinary conditions of use.

113×

UNSAFE COL

The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).

37213×

PESTICIDE2

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be adulterated because it contains a pesticide chemical, which is in violation of section 402(a)(2)(B). Contains:

38442×

SACCHARLBL

The article appears to contain Saccharin, a non-nutritive sweetener, and its label or labeling fails to list it as an added ingredient.

24612×

UNSFDIETUS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a dietary supplement or contain a dietary ingredient that renders it adulterated under section 402(a)(1) under the conditions of use recommended or suggested in the labeling of such dietary supplement.

2382×

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.

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.

20401×

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.

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.

24601×

UNSFDIETLB

The article appears to be a dietary supplement or contain a dietary ingredient that presents a significant or unreasonable risk of illness or injury under the conditions of use set out in the labeling or, if none are set out in the labeling, under customary conditions of use.

26401×

CYCLAMATE

The article appears to bear or contain cyclamate, an unsafe food additive within the meaning of Section 409

27201×

DULCIN

The article appears to bear or contain dulcin, an unsafe food additive within the meaning of Section 409

29201×

PESTICIDES

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be adulterated because it contains a pesticide chemical, which is in violation of section 402(a)(2)(B). Contains:

38621×

DIETARYING

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(A) of the FD&C Act in that the dietary supplement label or labeling fails to list the name of each dietary ingredient of the supplement and the quantity of each such dietary ingredient or , with respect to a proprietary blend of such dietary ingredients, the total quantity of all dietary ingredients in the blend.

Refusal History

DateProductViolationsDivision
4/28/2022
25PGH10FUNGUS, WHITE, WHOLE (BUTTON) (FUNGI)
249FILTHY
Division of West Coast Imports (DWCI)
11/24/2021
25SGH10FUNGUS, WHITE, FUNGI PRODUCTS, N.E.C.
249FILTHY
Division of West Coast Imports (DWCI)
10/22/2018
25SGH09FUNGUS, BLACK (CLOUD EARS), FUNGI PRODUCTS, N.E.C.
249FILTHY
Division of West Coast Imports (DWCI)
10/1/2018
21HGH08LOQUAT, DRIED OR PASTE
238UNSAFE ADD
3844SACCHARLBL
Division of West Coast Imports (DWCI)
10/1/2018
21TGH99SUBTROPICAL AND TROPICAL FRUIT, DRIED OR PASTE, N.E.C.
11UNSAFE COL
Division of West Coast Imports (DWCI)
10/1/2018
21TGH99SUBTROPICAL AND TROPICAL FRUIT, DRIED OR PASTE, N.E.C.
11UNSAFE COL
Division of West Coast Imports (DWCI)
10/1/2018
21TGH99SUBTROPICAL AND TROPICAL FRUIT, DRIED OR PASTE, N.E.C.
11UNSAFE COL
Division of West Coast Imports (DWCI)
4/4/2017
17YGH05GECKO
9SALMONELLA
Division of West Coast Imports (DWCI)
8/11/2016
20HGH04LEMON, DRIED OR PASTE
2040SULFITELBL
218LIST INGRE
2640CYCLAMATE
2720DULCIN
3844SACCHARLBL
3862DIETARYING
San Francisco District Office (SAN-DO)
6/2/2016
21HGH05DATES, DRIED OR PASTE
249FILTHY
San Francisco District Office (SAN-DO)
7/10/2014
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
3721PESTICIDE2
San Francisco District Office (SAN-DO)
2/24/2014
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
238UNSAFE ADD
San Francisco District Office (SAN-DO)
12/23/2013
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
3721PESTICIDE2
San Francisco District Office (SAN-DO)
11/8/2013
21HGH16CHINESE RED DATE (JUJUBES, ZIZIPHUS JUJUBA), DRIED OR PASTE
249FILTHY
San Francisco District Office (SAN-DO)
3/29/2013
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
3721PESTICIDE2
San Francisco District Office (SAN-DO)
1/25/2013
21HGH16CHINESE RED DATE (JUJUBES, ZIZIPHUS JUJUBA), DRIED OR PASTE
249FILTHY
San Francisco District Office (SAN-DO)
3/16/2011
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
249FILTHY
San Francisco District Office (SAN-DO)
11/5/2010
54FBT12GINSENG (HERBAL & BOTANICALS, NOT TEAS)
2920PESTICIDES
San Francisco District Office (SAN-DO)
10/19/2010
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
3120EPHEDALK
San Francisco District Office (SAN-DO)
6/22/2010
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
3120EPHEDALK
San Francisco District Office (SAN-DO)
6/18/2010
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
3120EPHEDALK
San Francisco District Office (SAN-DO)
6/18/2010
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
2460UNSFDIETLB
2461UNSFDIETUS
San Francisco District Office (SAN-DO)
10/20/2009
54ECT99HERBALS & BOTANICAL TEAS, N.E.C.
2461UNSFDIETUS
San Francisco District Office (SAN-DO)
10/20/2009
54ECT99HERBALS & BOTANICAL TEAS, N.E.C.
482NUTRIT LBL
San Francisco District Office (SAN-DO)
10/20/2009
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
482NUTRIT LBL
San Francisco District Office (SAN-DO)
10/20/2009
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
482NUTRIT LBL
San Francisco District Office (SAN-DO)
10/20/2009
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
482NUTRIT LBL
San Francisco District Office (SAN-DO)
10/20/2009
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
482NUTRIT LBL
San Francisco District Office (SAN-DO)
10/20/2009
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
482NUTRIT LBL
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Zhuhai City Tonghui Pharmaceutical Co.,Ltd.'s FDA import refusal history?

Zhuhai City Tonghui Pharmaceutical Co.,Ltd. (FEI: 3007512797) has 29 FDA import refusal record(s) in our database, spanning from 10/20/2009 to 4/28/2022.

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. Zhuhai City Tonghui Pharmaceutical Co.,Ltd.'s FEI number is 3007512797.

What types of violations has Zhuhai City Tonghui Pharmaceutical Co.,Ltd. received?

Zhuhai City Tonghui Pharmaceutical Co.,Ltd. has been cited for 16 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 Zhuhai City Tonghui Pharmaceutical Co.,Ltd. come from?

All FDA import refusal data for Zhuhai City Tonghui Pharmaceutical Co.,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.