Atul Pande
⚠️ Moderate Risk
FEI: 3004437248 • Bangalore, Karnataka • INDIA
FEI Number
3004437248
Location
Bangalore, Karnataka
Country
INDIAAddress
0 - 34 Diamond District, , Bangalore, Karnataka, 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).
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/20/2004 | 62VCA12RIBAVIRIN (ANTI-VIRAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/20/2004 | 62VCA12RIBAVIRIN (ANTI-VIRAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/20/2004 | 62LCA50METRONIDAZOLE HYDROCHLORIDE (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | 72NEW VET DR | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Atul Pande's FDA import refusal history?
Atul Pande (FEI: 3004437248) has 3 FDA import refusal record(s) in our database, spanning from 4/20/2004 to 4/20/2004.
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. Atul Pande's FEI number is 3004437248.
What types of violations has Atul Pande received?
Atul Pande 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 Atul Pande come from?
All FDA import refusal data for Atul Pande 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.