Simplicon
⚠️ Moderate Risk
FEI: 3008471614 • Mumbai, Maharashtra • INDIA
FEI Number
3008471614
Location
Mumbai, Maharashtra
Country
INDIAAddress
Asha Nagar Road, , Mumbai, Maharashtra, 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 |
|---|---|---|---|
| 9/15/2010 | 63ACA11IBANDRONATE SODIUM | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/15/2010 | 62TCA06ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/15/2010 | 61JCA16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/15/2010 | 62OCA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/15/2010 | 61PCA62PIOGLITAZONE HCL | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Simplicon's FDA import refusal history?
Simplicon (FEI: 3008471614) has 5 FDA import refusal record(s) in our database, spanning from 9/15/2010 to 9/15/2010.
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. Simplicon's FEI number is 3008471614.
What types of violations has Simplicon received?
Simplicon 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 Simplicon come from?
All FDA import refusal data for Simplicon 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.