YANGZHOU TRACEY DAILY CHEMICAL PLASTIC CO LTD
⚠️ High Risk
FEI: 3013648450 • Yangzhou, Jiangsu • CHINA
FEI Number
3013648450
Location
Yangzhou, Jiangsu
Country
CHINAAddress
Guanglingxincheng Building Floor No.9, Guangling District, Yangzhou, Jiangsu, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
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
DRG REF EI
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article of drug appears to be adulterated under Section 501(j) because it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/16/2025 | 62FAL27METHYLBENZETHONIUM CHLORIDE (ANTI-INFECTIVE, TOPICAL) | 3845DRG REF EI | Division of Northeast Imports (DNEI) |
| 1/16/2025 | 62FAL27METHYLBENZETHONIUM CHLORIDE (ANTI-INFECTIVE, TOPICAL) | 3845DRG REF EI | Division of Northeast Imports (DNEI) |
| 1/11/2021 | 55QY42BENZETHONIUM CHLORIDE (PHARMACEUTIC NECESSITY - PRESERVATIVE) | 3845DRG REF EI | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is YANGZHOU TRACEY DAILY CHEMICAL PLASTIC CO LTD's FDA import refusal history?
YANGZHOU TRACEY DAILY CHEMICAL PLASTIC CO LTD (FEI: 3013648450) has 3 FDA import refusal record(s) in our database, spanning from 1/11/2021 to 1/16/2025.
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 TRACEY DAILY CHEMICAL PLASTIC CO LTD's FEI number is 3013648450.
What types of violations has YANGZHOU TRACEY DAILY CHEMICAL PLASTIC CO LTD received?
YANGZHOU TRACEY DAILY CHEMICAL PLASTIC 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 TRACEY DAILY CHEMICAL PLASTIC CO LTD come from?
All FDA import refusal data for YANGZHOU TRACEY DAILY CHEMICAL PLASTIC 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.