A. MENARINI INDIA PVT. LTD.
⚠️ High Risk
FEI: 3016976064 • Mumbai, Maharashtra • INDIA
FEI Number
3016976064
Location
Mumbai, Maharashtra
Country
INDIAAddress
2102 Tower3, Senapati Bapat Marg, Mumbai, Maharashtra, 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 |
|---|---|---|---|
| 11/12/2024 | 63IDK01PODOPHYLLUM RESIN (CAUSTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is A. MENARINI INDIA PVT. LTD.'s FDA import refusal history?
A. MENARINI INDIA PVT. LTD. (FEI: 3016976064) has 1 FDA import refusal record(s) in our database, spanning from 11/12/2024 to 11/12/2024.
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. A. MENARINI INDIA PVT. LTD.'s FEI number is 3016976064.
What types of violations has A. MENARINI INDIA PVT. LTD. received?
A. MENARINI INDIA 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 A. MENARINI INDIA PVT. LTD. come from?
All FDA import refusal data for A. MENARINI INDIA 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.