Rakesh Dutt
⚠️ High Risk
FEI: 3008102815 • Ludhiana, Punjab • 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).
COL ADDED
The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/13/2011 | 62CIY99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/13/2011 | 60SIY22FAMOTIDINE (ANTACID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/13/2011 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/13/2011 | 61JIY99ANTI-CHOLESTEREMIC, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/13/2011 | 64UIY99INHIBITOR N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/13/2011 | 61JIY99ANTI-CHOLESTEREMIC, N.E.C. | New Orleans District Office (NOL-DO) | |
| 12/13/2011 | 61XIY45CETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/13/2011 | 61FIY54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Rakesh Dutt's FDA import refusal history?
Rakesh Dutt (FEI: 3008102815) has 8 FDA import refusal record(s) in our database, spanning from 12/13/2011 to 12/13/2011.
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. Rakesh Dutt's FEI number is 3008102815.
What types of violations has Rakesh Dutt received?
Rakesh Dutt 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 Rakesh Dutt come from?
All FDA import refusal data for Rakesh Dutt 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.