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Yangzhou Sion Commodity Co., Ltd.

⚠️ High Risk

FEI: 3011346498 • Yangzhou, Jiangsu • CHINA

FEI

FEI Number

3011346498

📍

Location

Yangzhou, Jiangsu

🇨🇳

Country

CHINA
🏢

Address

168 Longwang Road; Hangji Industrial Park, , Guangling, Yangzhou, Jiangsu, China

High Risk

FDA Import Risk Assessment

55.4
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

2
Total Refusals
1
Unique Violations
4/11/2025
Latest Refusal
2/13/2025
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
17.7×30%
Recency
80.5×20%
Frequency
20.0×10%
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

272×

DRUG GMPS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).

Refusal History

DateProductViolationsDivision
4/11/2025
63RBY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC)
27DRUG GMPS
Division of West Coast Imports (DWCI)
2/13/2025
63RBG04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)
27DRUG GMPS
Division of Southwest Imports (DSWI)

Frequently Asked Questions

What is Yangzhou Sion Commodity Co., Ltd.'s FDA import refusal history?

Yangzhou Sion Commodity Co., Ltd. (FEI: 3011346498) has 2 FDA import refusal record(s) in our database, spanning from 2/13/2025 to 4/11/2025.

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. Yangzhou Sion Commodity Co., Ltd.'s FEI number is 3011346498.

What types of violations has Yangzhou Sion Commodity Co., Ltd. received?

Yangzhou Sion Commodity Co., Ltd. has been cited for 1 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 Yangzhou Sion Commodity Co., Ltd. come from?

All FDA import refusal data for Yangzhou Sion Commodity 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.