Seth Medicos
⚠️ High Risk
FEI: 3007388700 • New Delhi, Delhi • INDIA
FEI Number
3007388700
Location
New Delhi, Delhi
Country
INDIAAddress
B - 4 Shopping Center, , New Delhi, Delhi, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/19/2009 | 62WCL99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/19/2009 | 64LDO67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/19/2009 | 64LCO06BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/19/2009 | 61WDA45FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/19/2009 | 61WCJ18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/19/2009 | 64LCJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Seth Medicos's FDA import refusal history?
Seth Medicos (FEI: 3007388700) has 6 FDA import refusal record(s) in our database, spanning from 3/19/2009 to 3/19/2009.
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. Seth Medicos's FEI number is 3007388700.
What types of violations has Seth Medicos received?
Seth Medicos 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 Seth Medicos come from?
All FDA import refusal data for Seth Medicos 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.