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Shandong Yuwang Pharmaceutical Co., Ltd

⚠️ Moderate Risk

FEI: 3010119104 • Dezhou, Shandong • CHINA

FEI

FEI Number

3010119104

📍

Location

Dezhou, Shandong

🇨🇳

Country

CHINA
🏢

Address

2731 Tong Qu Road, Yucheng, Dezhou, Shandong, China

Moderate Risk

FDA Import Risk Assessment

27.0
LowModerateHighCritical

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

Statistics

4
Total Refusals
3
Unique Violations
3/15/2022
Latest Refusal
3/21/2016
Earliest Refusal

Score Breakdown

Violation Severity
42.0×40%
Refusal Volume
25.9×30%
Recency
8.9×20%
Frequency
6.7×10%
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

2183×

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.

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

Refusal History

DateProductViolationsDivision
3/15/2022
54ACJ16VITAMIN E (TOCOPHEROL)
218LIST INGRE
Division of Southeast Imports (DSEI)
3/15/2022
54ECA99HERBALS & BOTANICAL TEAS, N.E.C.
218LIST INGRE
Division of Southeast Imports (DSEI)
12/6/2021
54ECA99HERBALS & BOTANICAL TEAS, N.E.C.
218LIST INGRE
473LABELING
Division of Southeast Imports (DSEI)
3/21/2016
66VBH99MISCELLANEOUS PATENT MEDICINES, ETC.
3280FRNMFGREG
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Shandong Yuwang Pharmaceutical Co., Ltd's FDA import refusal history?

Shandong Yuwang Pharmaceutical Co., Ltd (FEI: 3010119104) has 4 FDA import refusal record(s) in our database, spanning from 3/21/2016 to 3/15/2022.

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. Shandong Yuwang Pharmaceutical Co., Ltd's FEI number is 3010119104.

What types of violations has Shandong Yuwang Pharmaceutical Co., Ltd received?

Shandong Yuwang Pharmaceutical Co., Ltd has been cited for 3 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 Yuwang Pharmaceutical Co., Ltd come from?

All FDA import refusal data for Shandong Yuwang 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.