Zhuhai City Tonghui Pharmaceutical Co.,Ltd.
⚠️ High Risk
FEI: 3007512797 • Zhuhai, Guangdong • CHINA
FEI Number
3007512797
Location
Zhuhai, Guangdong
Country
CHINAAddress
Longshan Industrial, No. 10 Chisan Road; Doumen Town, Zhuhai, Guangdong, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
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
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.
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.
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.
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).
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:
SACCHARLBL
The article appears to contain Saccharin, a non-nutritive sweetener, and its label or labeling fails to list it as an added ingredient.
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.
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.
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.
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.
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.
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.
CYCLAMATE
The article appears to bear or contain cyclamate, an unsafe food additive within the meaning of Section 409
DULCIN
The article appears to bear or contain dulcin, an unsafe food additive within the meaning of Section 409
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:
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 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 | 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 | 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. | 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.