Qingdao Mehel Int'L Trading Co Ltd
⚠️ Moderate Risk
FEI: 3005796600 • Qingdao, Shandong • CHINA
FEI Number
3005796600
Location
Qingdao, Shandong
Country
CHINAAddress
NO. 18 Baodinglu, , 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
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.
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
RECORDS
The article appears to be a device and the requirements under 518 or to furnish any material or information required by or under section 519 respecting a device were not met.
Refusal History
Frequently Asked Questions
What is Qingdao Mehel Int'L Trading Co Ltd's FDA import refusal history?
Qingdao Mehel Int'L Trading Co Ltd (FEI: 3005796600) has 2 FDA import refusal record(s) in our database, spanning from 12/8/2006 to 10/22/2007.
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 Mehel Int'L Trading Co Ltd's FEI number is 3005796600.
What types of violations has Qingdao Mehel Int'L Trading Co Ltd received?
Qingdao Mehel Int'L Trading Co Ltd 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 Qingdao Mehel Int'L Trading Co Ltd come from?
All FDA import refusal data for Qingdao Mehel Int'L Trading 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.