Cosonic Electronic
⚠️ Moderate Risk
FEI: 3008753212 • Guanglang • 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).
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.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/14/2012 | 55QY64PROPYLENE GLYCOL (PHARMACEUTIC NECESSITY - SOLVENT) | 27DRUG GMPS | Cincinnati District Office (CIN-DO) |
| 4/14/2012 | 55QY64PROPYLENE GLYCOL (PHARMACEUTIC NECESSITY - SOLVENT) | 27DRUG GMPS | Cincinnati District Office (CIN-DO) |
| 4/14/2012 | 55QY64PROPYLENE GLYCOL (PHARMACEUTIC NECESSITY - SOLVENT) | 27DRUG GMPS | Cincinnati District Office (CIN-DO) |
| 4/14/2012 | 55QY64PROPYLENE GLYCOL (PHARMACEUTIC NECESSITY - SOLVENT) | 27DRUG GMPS | Cincinnati District Office (CIN-DO) |
| 4/14/2012 | 55QY64PROPYLENE GLYCOL (PHARMACEUTIC NECESSITY - SOLVENT) | 27DRUG GMPS | Cincinnati District Office (CIN-DO) |
| 4/14/2012 | 66BBL44NICOTINE DELIVERY SYSTEM | 27DRUG GMPS | Cincinnati District Office (CIN-DO) |
| 7/5/2011 | 55QY64PROPYLENE GLYCOL (PHARMACEUTIC NECESSITY - SOLVENT) | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Cosonic Electronic's FDA import refusal history?
Cosonic Electronic (FEI: 3008753212) has 7 FDA import refusal record(s) in our database, spanning from 7/5/2011 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 Electronic's FEI number is 3008753212.
What types of violations has Cosonic Electronic received?
Cosonic Electronic 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 Cosonic Electronic come from?
All FDA import refusal data for Cosonic Electronic 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.