Dafonti Nutripharm Inc.
⚠️ Moderate Risk
FEI: 2000007285 • Fort Lauderdale, FL • UNITED STATES
FEI Number
2000007285
Location
Fort Lauderdale, FL
Country
UNITED STATESAddress
1101 NW 51st St, , Fort Lauderdale, FL, 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
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.
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
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 Dafonti Nutripharm Inc.'s FDA import refusal history?
Dafonti Nutripharm Inc. (FEI: 2000007285) has 1 FDA import refusal record(s) in our database, spanning from 11/18/2010 to 11/18/2010.
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. Dafonti Nutripharm Inc.'s FEI number is 2000007285.
What types of violations has Dafonti Nutripharm Inc. received?
Dafonti Nutripharm Inc. has been cited for 3 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 Dafonti Nutripharm Inc. come from?
All FDA import refusal data for Dafonti Nutripharm 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.