Qingdao Enpu Household Products
⚠️ Moderate Risk
FEI: 3007500499 • Qingdao, Shandong • CHINA
FEI Number
3007500499
Location
Qingdao, Shandong
Country
CHINAAddress
NO. 2, Xiaozhou, Qingdao, Shandong, 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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/2/2015 | 76LQZDEVICE, JAW REPOSITIONING | New York District Office (NYK-DO) | |
| 2/2/2015 | 76EJBHANDLE, INSTRUMENT, DENTAL | New York District Office (NYK-DO) | |
| 2/2/2015 | 76LQZDEVICE, JAW REPOSITIONING | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Qingdao Enpu Household Products's FDA import refusal history?
Qingdao Enpu Household Products (FEI: 3007500499) has 3 FDA import refusal record(s) in our database, spanning from 2/2/2015 to 2/2/2015.
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. Qingdao Enpu Household Products's FEI number is 3007500499.
What types of violations has Qingdao Enpu Household Products received?
Qingdao Enpu Household Products 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 Qingdao Enpu Household Products come from?
All FDA import refusal data for Qingdao Enpu Household Products 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.