NITIN MEDICOS
⚠️ Moderate Risk
FEI: 3012807178 • New Delhi, Delhi • INDIA
FEI Number
3012807178
Location
New Delhi, Delhi
Country
INDIAAddress
Vasan, Pocket 1; Paschim Puri, New Delhi, Delhi, 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 |
|---|---|---|---|
| 10/25/2016 | 61HCA43LEVOFLOXACIN (ANTI-BACTERIAL, PART III) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 10/25/2016 | 62TCA07PANTOPRAZOLE SODIUM | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 10/25/2016 | 61NCA76PAROXETINE (ANTI-DEPRESSANT) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 10/25/2016 | 60SCA27RABEPRAZOLE SODIUM (ANTACID) (ANTI-ULCER) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is NITIN MEDICOS's FDA import refusal history?
NITIN MEDICOS (FEI: 3012807178) has 4 FDA import refusal record(s) in our database, spanning from 10/25/2016 to 10/25/2016.
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. NITIN MEDICOS's FEI number is 3012807178.
What types of violations has NITIN MEDICOS received?
NITIN 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 NITIN MEDICOS come from?
All FDA import refusal data for NITIN 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.