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Shandong Huaxian Stevia Co., Ltd.

⚠️ Moderate Risk

FEI: 3003311757 • Jining, Shandong • CHINA

FEI

FEI Number

3003311757

📍

Location

Jining, Shandong

🇨🇳

Country

CHINA
🏢

Address

Xianzhuang Nanzhang Ren Cheng, , Jining, Shandong, China

Moderate Risk

FDA Import Risk Assessment

31.1
LowModerateHighCritical

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

Statistics

4
Total Refusals
7
Unique Violations
9/15/2014
Latest Refusal
2/21/2012
Earliest Refusal

Score Breakdown

Violation Severity
54.4×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
15.6×10%
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

2383×

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.

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)).

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

3211×

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.

3281×

USUAL NAME

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)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be.

3331×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

3201×

LACKS FIRM

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)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.

Refusal History

DateProductViolationsDivision
9/15/2014
54FBR99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
238UNSAFE ADD
Los Angeles District Office (LOS-DO)
8/19/2014
54FBR99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
238UNSAFE ADD
Los Angeles District Office (LOS-DO)
4/13/2012
45TY99ALL OTHER PRODUCTS, NON-NUTRITIVE SWEETENERS
238UNSAFE ADD
256INCONSPICU
320LACKS FIRM
321LACKS N/C
328USUAL NAME
333LACKS FIRM
New Orleans District Office (NOL-DO)
2/21/2012
66HAR99SWEETENER N.E.C.
16DIRECTIONS
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Shandong Huaxian Stevia Co., Ltd.'s FDA import refusal history?

Shandong Huaxian Stevia Co., Ltd. (FEI: 3003311757) has 4 FDA import refusal record(s) in our database, spanning from 2/21/2012 to 9/15/2014.

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. Shandong Huaxian Stevia Co., Ltd.'s FEI number is 3003311757.

What types of violations has Shandong Huaxian Stevia Co., Ltd. received?

Shandong Huaxian Stevia 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 Shandong Huaxian Stevia Co., Ltd. come from?

All FDA import refusal data for Shandong Huaxian Stevia 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.