UNICURE INDIA LTD (UNIT II)
⚠️ High Risk
FEI: 3030956662 • Roorkee • INDIA
FEI Number
3030956662
Location
Roorkee
Country
INDIAAddress
46 (B)/ 49/B Village Ra, , Roorkee, , 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 |
|---|---|---|---|
| 6/17/2024 | 65JDY20MEDROGESTONE (PROGESTIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is UNICURE INDIA LTD (UNIT II)'s FDA import refusal history?
UNICURE INDIA LTD (UNIT II) (FEI: 3030956662) has 1 FDA import refusal record(s) in our database, spanning from 6/17/2024 to 6/17/2024.
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. UNICURE INDIA LTD (UNIT II)'s FEI number is 3030956662.
What types of violations has UNICURE INDIA LTD (UNIT II) received?
UNICURE INDIA LTD (UNIT II) 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 UNICURE INDIA LTD (UNIT II) come from?
All FDA import refusal data for UNICURE INDIA LTD (UNIT II) 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.