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HER SHENG ENTERPRISE CO., LTD

⚠️ Moderate Risk

FEI: 2000009344 • Tsao Tuan Town, Nantou • TAIWAN

FEI

FEI Number

2000009344

📍

Location

Tsao Tuan Town, Nantou

🇹🇼

Country

TAIWAN
🏢

Address

No. 53 Ru Lin St., , Tsao Tuan Town, Nantou, Taiwan

Moderate Risk

FDA Import Risk Assessment

32.5
LowModerateHighCritical

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

Statistics

4
Total Refusals
7
Unique Violations
6/23/2017
Latest Refusal
8/15/2011
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
6.8×10%
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

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.

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.

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.

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)).

621×

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).

3081×

MFR INSAN

The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.

2561×

INCONSPICU

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
6/23/2017
16ACI99FISH, N.E.C.
218LIST INGRE
256INCONSPICU
260FALSE
308MFR INSAN
Division of West Coast Imports (DWCI)
4/22/2014
37JGE17BEAN, GROUND SAUCE
218LIST INGRE
324NO ENGLISH
83NO PROCESS
New York District Office (NYK-DO)
3/3/2014
37JCE03CHILI SAUCE
83NO PROCESS
New York District Office (NYK-DO)
8/15/2011
37KCI99PASTES, N.E.C.
62NEEDS FCE
83NO PROCESS
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is HER SHENG ENTERPRISE CO., LTD's FDA import refusal history?

HER SHENG ENTERPRISE CO., LTD (FEI: 2000009344) has 4 FDA import refusal record(s) in our database, spanning from 8/15/2011 to 6/23/2017.

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. HER SHENG ENTERPRISE CO., LTD's FEI number is 2000009344.

What types of violations has HER SHENG ENTERPRISE CO., LTD received?

HER SHENG ENTERPRISE CO., LTD has been cited for 7 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 HER SHENG ENTERPRISE CO., LTD come from?

All FDA import refusal data for HER SHENG ENTERPRISE 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.