HSIN TUNG YANG CO., LTD.
⚠️ Moderate Risk
FEI: 3000218299 • Taiepi, TW-TPE • TAIWAN
FEI Number
3000218299
Location
Taiepi, TW-TPE
Country
TAIWANAddress
8F,289 CHUNG HSIAO E.RD., SEC. 4, , Taiepi, TW-TPE, Taiwan
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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
LACKS N/C
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)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
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.
NEEDS ACID
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health due to inadequate acidification.
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.
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
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.
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.
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.
PRESRV LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a chemical preservative and it fails to bear labeling stating that fact including its function.
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)).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/7/2019 | 24TET03BAMBOO SHOOTS (LEAF & STEM VEGETABLE) | Division of Northeast Imports (DNEI) | |
| 4/1/2015 | 03RGT01CAKE WITHOUT CUSTARD OR CREAM FILLING | San Francisco District Office (SAN-DO) | |
| 5/13/2011 | 24UGH03BAMBOO SHOOTS, DRIED OR PASTE | New York District Office (NYK-DO) | |
| 4/6/2011 | 24AGT99BEANS, CORN, AND PEA, N.E.C. (VEGETABLE) | 2040SULFITELBL | New York District Office (NYK-DO) |
| 8/6/2009 | 16IEE43TOTOAVA (WHITE SEA BASS), HOT SMOKED, FISH | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 5/21/2007 | 25JGT07RADISH (ROOT & TUBER VEGETABLE) | New York District Office (NYK-DO) | |
| 6/20/2005 | 28KGT04MEAT TENDERIZER, GROUND, CRACKED, WITH SALT | San Francisco District Office (SAN-DO) | |
| 5/26/2005 | 25JGP07RADISH (ROOT & TUBER VEGETABLE) | 48NEEDS ACID | San Francisco District Office (SAN-DO) |
| 5/26/2005 | 37BCP30BEAN CURD CUBES, FERMENTED (E.G., SALTED) IN OIL/SAUCE/ WINE, ETC. (MULT FOOD SPEC/SIDE DISH/DESSERT | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is HSIN TUNG YANG CO., LTD.'s FDA import refusal history?
HSIN TUNG YANG CO., LTD. (FEI: 3000218299) has 9 FDA import refusal record(s) in our database, spanning from 5/26/2005 to 10/7/2019.
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. HSIN TUNG YANG CO., LTD.'s FEI number is 3000218299.
What types of violations has HSIN TUNG YANG CO., LTD. received?
HSIN TUNG YANG CO., LTD. has been cited for 11 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 HSIN TUNG YANG CO., LTD. come from?
All FDA import refusal data for HSIN TUNG YANG 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.