MEDSHARE INTERNATIONAL INC
⚠️ High Risk
FEI: 3016649827 • Decatur, GA • UNITED STATES
FEI Number
3016649827
Location
Decatur, GA
Country
UNITED STATESAddress
3240 Clifton Springs Rd, , Decatur, GA, United States
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
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
Frequently Asked Questions
What is MEDSHARE INTERNATIONAL INC's FDA import refusal history?
MEDSHARE INTERNATIONAL INC (FEI: 3016649827) has 2 FDA import refusal record(s) in our database, spanning from 6/13/2025 to 6/13/2025.
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. MEDSHARE INTERNATIONAL INC's FEI number is 3016649827.
What types of violations has MEDSHARE INTERNATIONAL INC received?
MEDSHARE INTERNATIONAL INC has been cited for 1 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 MEDSHARE INTERNATIONAL INC come from?
All FDA import refusal data for MEDSHARE INTERNATIONAL INC 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.