Fresinius Medical Care North Ame
⚠️ Moderate Risk
FEI: 3002763717 • Lexington, MA • UNITED STATES
FEI Number
3002763717
Location
Lexington, MA
Country
UNITED STATESAddress
95 Hayden Ave, , Lexington, MA, United States
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
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/15/2003 | 78FKJFILTER, BLOOD, DIALYSIS | 237NO PMA | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Fresinius Medical Care North Ame's FDA import refusal history?
Fresinius Medical Care North Ame (FEI: 3002763717) has 1 FDA import refusal record(s) in our database, spanning from 5/15/2003 to 5/15/2003.
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. Fresinius Medical Care North Ame's FEI number is 3002763717.
What types of violations has Fresinius Medical Care North Ame received?
Fresinius Medical Care North Ame 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 Fresinius Medical Care North Ame come from?
All FDA import refusal data for Fresinius Medical Care North Ame 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.