Ophmed Company Ltd
✅ Low Risk
FEI: 3008406231 • Nanjing City • CHINA
FEI Number
3008406231
Location
Nanjing City
Country
CHINAAddress
304 No 329 Middle, , Nanjing City, , China
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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
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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
Refusal History
Frequently Asked Questions
What is Ophmed Company Ltd's FDA import refusal history?
Ophmed Company Ltd (FEI: 3008406231) has 1 FDA import refusal record(s) in our database, spanning from 7/20/2010 to 7/20/2010.
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. Ophmed Company Ltd's FEI number is 3008406231.
What types of violations has Ophmed Company Ltd received?
Ophmed Company 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 Ophmed Company Ltd come from?
All FDA import refusal data for Ophmed Company 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.