TIRUPATI LIFESCIENCES
⚠️ High Risk
FEI: 3017030640 • Paonta Sahib • INDIA
FEI Number
3017030640
Location
Paonta Sahib
Country
INDIAAddress
Nahan Road, Dist Sirmou, , Paonta Sahib, , 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).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/12/2026 | 54AGA17BIOTIN (VITAMIN H, COENZYME R) | Division of Southeast Imports (DSEI) | |
| 10/1/2024 | 65RDA99REPLENISHER N.E.C. | Division of Southeast Imports (DSEI) | |
| 9/20/2024 | 66YDY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/20/2024 | 66YDY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/4/2022 | 54FBY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/4/2022 | 54FBY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/4/2022 | 54FBY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/27/2022 | 66VIL99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 9/27/2022 | 66VIL99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 9/27/2022 | 66VIL99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 9/27/2022 | 66VIL99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 8/8/2017 | 54CCA13L-LYSINE (PROTEIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/8/2017 | 54CCA13L-LYSINE (PROTEIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/8/2017 | 54CCA13L-LYSINE (PROTEIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is TIRUPATI LIFESCIENCES's FDA import refusal history?
TIRUPATI LIFESCIENCES (FEI: 3017030640) has 14 FDA import refusal record(s) in our database, spanning from 8/8/2017 to 1/12/2026.
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. TIRUPATI LIFESCIENCES's FEI number is 3017030640.
What types of violations has TIRUPATI LIFESCIENCES received?
TIRUPATI LIFESCIENCES has been cited for 2 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 TIRUPATI LIFESCIENCES come from?
All FDA import refusal data for TIRUPATI LIFESCIENCES 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.