WINDLAS BIOTECH LIMITED PLANT IV
⚠️ High Risk
FEI: 3025804403 • Dehradun Uttarakhand • INDIA
FEI Number
3025804403
Location
Dehradun Uttarakhand
Country
INDIAAddress
Plot No. 183 & 192 Moh, , Dehradun Uttarakhand, , India
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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/22/2024 | 62CCA41MINOXIDIL (ANTI-HYPERTENSIVE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is WINDLAS BIOTECH LIMITED PLANT IV's FDA import refusal history?
WINDLAS BIOTECH LIMITED PLANT IV (FEI: 3025804403) has 1 FDA import refusal record(s) in our database, spanning from 11/22/2024 to 11/22/2024.
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. WINDLAS BIOTECH LIMITED PLANT IV's FEI number is 3025804403.
What types of violations has WINDLAS BIOTECH LIMITED PLANT IV received?
WINDLAS BIOTECH LIMITED PLANT IV 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 WINDLAS BIOTECH LIMITED PLANT IV come from?
All FDA import refusal data for WINDLAS BIOTECH LIMITED PLANT IV 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.