Infusion Specialists
⚠️ Moderate Risk
FEI: 3012005911 • New York, NY • UNITED STATES
FEI Number
3012005911
Location
New York, NY
Country
UNITED STATESAddress
123 W 79th St, , New York, NY, 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
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
Frequently Asked Questions
What is Infusion Specialists's FDA import refusal history?
Infusion Specialists (FEI: 3012005911) has 2 FDA import refusal record(s) in our database, spanning from 2/8/2016 to 2/8/2016.
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. Infusion Specialists's FEI number is 3012005911.
What types of violations has Infusion Specialists received?
Infusion Specialists 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 Infusion Specialists come from?
All FDA import refusal data for Infusion Specialists 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.