Niksun India Pvt
⚠️ Moderate Risk
FEI: 3005828290 • New Delhi • INDIA
FEI Number
3005828290
Location
New Delhi
Country
INDIAAddress
Sco 16 Sector 14, , New 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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
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 |
|---|---|---|---|
| 9/5/2006 | 61PCB26METFORMIN (ANTI-DIABETIC) | New York District Office (NYK-DO) | |
| 9/5/2006 | 60XCA02METOPROLOL (ANTI-ADRENERGIC) | New York District Office (NYK-DO) | |
| 9/5/2006 | 64BCA27ISOSORBIDE (DIURETIC) | New York District Office (NYK-DO) | |
| 9/5/2006 | 66MCA86LORAZEPAM (TRANQUILIZER) | New York District Office (NYK-DO) | |
| 9/5/2006 | 61NCA03AMITRIPTYLINE HCL (ANTI-DEPRESSANT) | New York District Office (NYK-DO) | |
| 9/5/2006 | 61JCA12LOVASTATIN (ANTI-CHOLESTEREMIC) | New York District Office (NYK-DO) | |
| 9/5/2006 | 62OCA05RAMIPRIL (ANTI-HYPERTENSIVE - PART II) | New York District Office (NYK-DO) | |
| 9/5/2006 | 66SCA03BETAHISTINE HCL (VASODILATOR) | New York District Office (NYK-DO) | |
| 9/5/2006 | 61LCA38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | New York District Office (NYK-DO) | |
| 9/5/2006 | 66VCB99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Niksun India Pvt's FDA import refusal history?
Niksun India Pvt (FEI: 3005828290) has 10 FDA import refusal record(s) in our database, spanning from 9/5/2006 to 9/5/2006.
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. Niksun India Pvt's FEI number is 3005828290.
What types of violations has Niksun India Pvt received?
Niksun India Pvt 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 Niksun India Pvt come from?
All FDA import refusal data for Niksun India Pvt 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.