Novartis Institues Of Biomedical
⚠️ Moderate Risk
FEI: 3009157413 • Fort Worth, TX • UNITED STATES
FEI Number
3009157413
Location
Fort Worth, TX
Country
UNITED STATESAddress
6201 South Fwy # R2-39, , Fort Worth, TX, 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 Novartis Institues Of Biomedical's FDA import refusal history?
Novartis Institues Of Biomedical (FEI: 3009157413) has 2 FDA import refusal record(s) in our database, spanning from 1/27/2022 to 1/27/2022.
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. Novartis Institues Of Biomedical's FEI number is 3009157413.
What types of violations has Novartis Institues Of Biomedical received?
Novartis Institues Of Biomedical 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 Novartis Institues Of Biomedical come from?
All FDA import refusal data for Novartis Institues Of Biomedical 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.