Changzhou Daya Import & Export Corp
⚠️ Moderate Risk
FEI: 3009078948 • Changzhou, Jiangsu • CHINA
FEI Number
3009078948
Location
Changzhou, Jiangsu
Country
CHINAAddress
Sanjing Building, Floor 6-8, NO. 8 Tongjiang Road, Xinbei, Changzhou, Jiangsu, 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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/16/2010 | 62SDJ99ANTI-SEBORRHEIC N.E.C. | 483DRUG NAME | Los Angeles District Office (LOS-DO) |
| 4/16/2010 | 89IPFSTIMULATOR, MUSCLE, POWERED | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 4/16/2010 | 60QDJ34DIBUCAINE (ANESTHETIC) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 4/16/2010 | 62FDJ99ANTI-INFECTIVE, TOPICAL N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Changzhou Daya Import & Export Corp's FDA import refusal history?
Changzhou Daya Import & Export Corp (FEI: 3009078948) has 4 FDA import refusal record(s) in our database, spanning from 4/16/2010 to 4/16/2010.
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. Changzhou Daya Import & Export Corp's FEI number is 3009078948.
What types of violations has Changzhou Daya Import & Export Corp received?
Changzhou Daya Import & Export Corp has been cited for 2 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 Changzhou Daya Import & Export Corp come from?
All FDA import refusal data for Changzhou Daya Import & Export Corp 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.