Cosonic Electronics Co Ltd
⚠️ Moderate Risk
FEI: 3008295323 • Dongguandongguan • CHINA
FEI Number
3008295323
Location
Dongguandongguan
Country
CHINAAddress
Shi Pai Town, , Dongguandongguan, , China
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/14/2012 | 66BDL44NICOTINE DELIVERY SYSTEM | 27DRUG GMPS | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Cosonic Electronics Co Ltd's FDA import refusal history?
Cosonic Electronics Co Ltd (FEI: 3008295323) has 1 FDA import refusal record(s) in our database, spanning from 4/14/2012 to 4/14/2012.
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. Cosonic Electronics Co Ltd's FEI number is 3008295323.
What types of violations has Cosonic Electronics Co Ltd received?
Cosonic Electronics 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 Cosonic Electronics Co Ltd come from?
All FDA import refusal data for Cosonic Electronics 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.