Chong Qin Boerni
⚠️ Moderate Risk
FEI: 3011132830 • Yiwu • 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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/8/2016 | 60QBO99ANESTHETIC, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 3/8/2016 | 60QBO99ANESTHETIC, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 12/12/2014 | 62FBJ99ANTI-INFECTIVE, TOPICAL N.E.C. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Chong Qin Boerni's FDA import refusal history?
Chong Qin Boerni (FEI: 3011132830) has 3 FDA import refusal record(s) in our database, spanning from 12/12/2014 to 3/8/2016.
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. Chong Qin Boerni's FEI number is 3011132830.
What types of violations has Chong Qin Boerni received?
Chong Qin Boerni 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 Chong Qin Boerni come from?
All FDA import refusal data for Chong Qin Boerni 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.