Unicure Remedies Pvt. Ltd.
⚠️ High Risk
FEI: 3004730446 • Vadodara, Gujarat • INDIA
FEI Number
3004730446
Location
Vadodara, Gujarat
Country
INDIAAddress
F25 Gorwa, , Vadodara, Gujarat, 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 |
|---|---|---|---|
| 4/26/2012 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/27/2011 | 66SCA51TADALAFIL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/8/2006 | 66SCB51TADALAFIL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/8/2006 | 66SCB51TADALAFIL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/27/2006 | 65PCB02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/27/2006 | 66SCB51TADALAFIL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/27/2006 | 66SCB51TADALAFIL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/25/2006 | 66SCA51TADALAFIL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/25/2006 | 66SCA51TADALAFIL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/25/2006 | 66SCA51TADALAFIL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/25/2006 | 66SCA51TADALAFIL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/25/2006 | 66SCA51TADALAFIL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/25/2006 | 66SCA51TADALAFIL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/25/2006 | 66SCA51TADALAFIL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/25/2006 | 66SCA51TADALAFIL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/25/2006 | 66SCA51TADALAFIL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/25/2006 | 66SCA51TADALAFIL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/25/2006 | 66SCA51TADALAFIL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/25/2006 | 66SCA51TADALAFIL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/25/2006 | 66SCA51TADALAFIL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/25/2006 | 66SCA51TADALAFIL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/25/2006 | 66SCA51TADALAFIL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/25/2006 | 66SCA51TADALAFIL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/25/2006 | 66SCA51TADALAFIL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/25/2006 | 66SCA51TADALAFIL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/25/2006 | 66SCA51TADALAFIL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/25/2006 | 66SCA51TADALAFIL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/25/2006 | 66SCA51TADALAFIL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/25/2006 | 66SCA51TADALAFIL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/25/2006 | 66SCA51TADALAFIL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/24/2006 | 66SCA51TADALAFIL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/24/2006 | 66SCA51TADALAFIL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/24/2006 | 66SCA51TADALAFIL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/24/2006 | 66SCA51TADALAFIL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/24/2006 | 66SCA51TADALAFIL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/24/2006 | 66SCA51TADALAFIL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/24/2006 | 66SCA51TADALAFIL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/24/2006 | 66SCA51TADALAFIL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/24/2006 | 66SCA51TADALAFIL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/24/2006 | 66SCA51TADALAFIL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Unicure Remedies Pvt. Ltd.'s FDA import refusal history?
Unicure Remedies Pvt. Ltd. (FEI: 3004730446) has 40 FDA import refusal record(s) in our database, spanning from 4/24/2006 to 4/26/2012.
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 Remedies Pvt. Ltd.'s FEI number is 3004730446.
What types of violations has Unicure Remedies Pvt. Ltd. received?
Unicure Remedies Pvt. Ltd. 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 Remedies Pvt. Ltd. come from?
All FDA import refusal data for Unicure Remedies Pvt. Ltd. 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.