Triguna
⚠️ Moderate Risk
FEI: 3003485096 • New Delhi, Delhi • INDIA
FEI Number
3003485096
Location
New Delhi, Delhi
Country
INDIAAddress
143, , New Delhi, Delhi, 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
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
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 |
|---|---|---|---|
| 4/4/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 483DRUG NAME | New Orleans District Office (NOL-DO) |
| 3/6/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 473LABELING | New Orleans District Office (NOL-DO) |
| 3/6/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 473LABELING | New Orleans District Office (NOL-DO) |
| 3/6/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 473LABELING | New Orleans District Office (NOL-DO) |
| 11/27/2001 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Triguna's FDA import refusal history?
Triguna (FEI: 3003485096) has 5 FDA import refusal record(s) in our database, spanning from 11/27/2001 to 4/4/2002.
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. Triguna's FEI number is 3003485096.
What types of violations has Triguna received?
Triguna has been cited for 3 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 Triguna come from?
All FDA import refusal data for Triguna 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.