Changning Dekang Biotechnology Co.,
⚠️ Moderate Risk
FEI: 3007645740 • Kunmingkunming • CHINA
FEI Number
3007645740
Location
Kunmingkunming
Country
CHINAAddress
Level 2, Linjie Buildingshilichang, , Kunmingkunming, , 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
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).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/6/2009 | 80MSNCIGARETTES (CONTAINING TOBACCO) | Seattle District Office (SEA-DO) | |
| 11/6/2009 | 80MSNCIGARETTES (CONTAINING TOBACCO) | Seattle District Office (SEA-DO) | |
| 8/20/2009 | 66BAL44NICOTINE DELIVERY SYSTEM | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Changning Dekang Biotechnology Co.,'s FDA import refusal history?
Changning Dekang Biotechnology Co., (FEI: 3007645740) has 3 FDA import refusal record(s) in our database, spanning from 8/20/2009 to 11/6/2009.
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. Changning Dekang Biotechnology Co.,'s FEI number is 3007645740.
What types of violations has Changning Dekang Biotechnology Co., received?
Changning Dekang Biotechnology Co., 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 Changning Dekang Biotechnology Co., come from?
All FDA import refusal data for Changning Dekang Biotechnology Co., 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.