Torrent Pharmaceuticals Limited
⚠️ Moderate Risk
FEI: 3012740315 • Gandhinagar, Gujarat • INDIA
FEI Number
3012740315
Location
Gandhinagar, Gujarat
Country
INDIAAddress
Unit-2, Survey No. 102, 105, 106, 119 to 121, Ahmedabad - Mehsana Highway, Bileshwarpura,Taluka-Kalol, , Gandhinagar, Gujarat, 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 |
|---|---|---|---|
| 2/15/2018 | 62ODY12VALSARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/9/2017 | 61TCY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/8/2017 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/9/2017 | 61TDE31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Torrent Pharmaceuticals Limited's FDA import refusal history?
Torrent Pharmaceuticals Limited (FEI: 3012740315) has 4 FDA import refusal record(s) in our database, spanning from 3/9/2017 to 2/15/2018.
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. Torrent Pharmaceuticals Limited's FEI number is 3012740315.
What types of violations has Torrent Pharmaceuticals Limited received?
Torrent Pharmaceuticals 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 Torrent Pharmaceuticals Limited come from?
All FDA import refusal data for Torrent Pharmaceuticals 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.