Shenzhen Keimeier Technology Co. LTD
⚠️ Moderate Risk
FEI: 3007683630 • Shenzhen, Guangdong • CHINA
FEI Number
3007683630
Location
Shenzhen, Guangdong
Country
CHINAAddress
Ba F 6, Huancheng Road; Xixiang, Shenzhen, Guangdong, 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
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
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
Frequently Asked Questions
What is Shenzhen Keimeier Technology Co. LTD's FDA import refusal history?
Shenzhen Keimeier Technology Co. LTD (FEI: 3007683630) has 1 FDA import refusal record(s) in our database, spanning from 12/7/2009 to 12/7/2009.
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. Shenzhen Keimeier Technology Co. LTD's FEI number is 3007683630.
What types of violations has Shenzhen Keimeier Technology Co. LTD received?
Shenzhen Keimeier Technology Co. LTD 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 Shenzhen Keimeier Technology Co. LTD come from?
All FDA import refusal data for Shenzhen Keimeier Technology Co. LTD 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.