Inventia Healthcare Limited
⚠️ Moderate Risk
FEI: 3008232264 • Thane, Maharashtra • INDIA
FEI Number
3008232264
Location
Thane, Maharashtra
Country
INDIAAddress
F1- F 1/1, Additional Ambernath Midc, Ambernath (East), Thane, Maharashtra, India
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
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 |
|---|---|---|---|
| 10/28/2021 | 60SCY27RABEPRAZOLE SODIUM (ANTACID) (ANTI-ULCER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/12/2021 | 61PDA26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 9/24/2020 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/15/2020 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/29/2020 | 61TCY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/9/2016 | 61NCE69GABAPENTIN (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 12/9/2014 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/13/2011 | 61PCA55METFORMIN HCL (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Inventia Healthcare Limited's FDA import refusal history?
Inventia Healthcare Limited (FEI: 3008232264) has 8 FDA import refusal record(s) in our database, spanning from 9/13/2011 to 10/28/2021.
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. Inventia Healthcare Limited's FEI number is 3008232264.
What types of violations has Inventia Healthcare Limited received?
Inventia Healthcare Limited 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 Inventia Healthcare Limited come from?
All FDA import refusal data for Inventia Healthcare Limited 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.