K.R. Sebastian
⚠️ Moderate Risk
FEI: 3008290651 • Kotathur • INDIA
FEI Number
3008290651
Location
Kotathur
Country
INDIAAddress
20/7/8,5th St Anjugam Nagar, , Kotathur, , 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 |
|---|---|---|---|
| 5/18/2010 | 61WDJ04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 5/18/2010 | 61XCA45CETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 5/18/2010 | 60SCA25RANITIDINE HYDROCHLORIDE (ANTACID) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 5/18/2010 | 61ACA99ANTI-AMEBIC, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is K.R. Sebastian's FDA import refusal history?
K.R. Sebastian (FEI: 3008290651) has 4 FDA import refusal record(s) in our database, spanning from 5/18/2010 to 5/18/2010.
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. K.R. Sebastian's FEI number is 3008290651.
What types of violations has K.R. Sebastian received?
K.R. Sebastian 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 K.R. Sebastian come from?
All FDA import refusal data for K.R. Sebastian 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.