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HSIN TUNG YANG CO., LTD.

⚠️ Moderate Risk

FEI: 3000218299 • Taiepi, TW-TPE • TAIWAN

FEI

FEI Number

3000218299

📍

Location

Taiepi, TW-TPE

🇹🇼

Country

TAIWAN
🏢

Address

8F,289 CHUNG HSIAO E.RD., SEC. 4, , Taiepi, TW-TPE, Taiwan

Moderate Risk

FDA Import Risk Assessment

35.2
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

9
Total Refusals
11
Unique Violations
10/7/2019
Latest Refusal
5/26/2005
Earliest Refusal

Score Breakdown

Violation Severity
58.6×40%
Refusal Volume
37.0×30%
Recency
0.0×20%
Frequency
6.3×10%
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

3213×

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.

833×

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.

4823×

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.

482×

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.

20402×

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.

622×

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).

2182×

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.

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.

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.

2761×

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.

3241×

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

DateProductViolationsDivision
10/7/2019
24TET03BAMBOO SHOOTS (LEAF & STEM VEGETABLE)
2040SULFITELBL
62NEEDS FCE
83NO PROCESS
Division of Northeast Imports (DNEI)
4/1/2015
03RGT01CAKE WITHOUT CUSTARD OR CREAM FILLING
218LIST INGRE
276PRESRV LBL
321LACKS N/C
482NUTRIT LBL
San Francisco District Office (SAN-DO)
5/13/2011
24UGH03BAMBOO SHOOTS, DRIED OR PASTE
218LIST INGRE
260FALSE
482NUTRIT LBL
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)
62NEEDS FCE
83NO PROCESS
New York District Office (NYK-DO)
6/20/2005
28KGT04MEAT TENDERIZER, GROUND, CRACKED, WITH SALT
321LACKS N/C
324NO ENGLISH
482NUTRIT LBL
9SALMONELLA
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
321LACKS N/C
48NEEDS ACID
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.