Shenzhen Kemeier T
⚠️ Moderate Risk
FEI: 3008032868 • Shenzhen • CHINA
FEI Number
3008032868
Location
Shenzhen
Country
CHINAAddress
6f B1 Bldg Ante In, , Shenzhen, , 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).
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/12/2010 | 66BAY44NICOTINE DELIVERY SYSTEM | New Orleans District Office (NOL-DO) | |
| 11/12/2010 | 77EPNPUMP, NEBULIZER, MANUAL | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 9/14/2010 | 66BAY44NICOTINE DELIVERY SYSTEM | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/18/2009 | 80MSNCIGARETTES (CONTAINING TOBACCO) | Seattle District Office (SEA-DO) | |
| 12/18/2009 | 80MSNCIGARETTES (CONTAINING TOBACCO) | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Shenzhen Kemeier T's FDA import refusal history?
Shenzhen Kemeier T (FEI: 3008032868) has 5 FDA import refusal record(s) in our database, spanning from 12/18/2009 to 11/12/2010.
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. Shenzhen Kemeier T's FEI number is 3008032868.
What types of violations has Shenzhen Kemeier T received?
Shenzhen Kemeier T has been cited for 4 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 Shenzhen Kemeier T come from?
All FDA import refusal data for Shenzhen Kemeier T 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.