Organon (India) Limited
⚠️ Moderate Risk
FEI: 3004134205 • Kolkata, West Bengal • INDIA
FEI Number
3004134205
Location
Kolkata, West Bengal
Country
INDIAAddress
38 B Chowringhee Road, , Kolkata, West Bengal, 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
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/13/2003 | 60NDB14TESTOSTERONE (ANDROGEN) | 342PERSONALRX | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Organon (India) Limited's FDA import refusal history?
Organon (India) Limited (FEI: 3004134205) has 1 FDA import refusal record(s) in our database, spanning from 10/13/2003 to 10/13/2003.
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. Organon (India) Limited's FEI number is 3004134205.
What types of violations has Organon (India) Limited received?
Organon (India) Limited 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 Organon (India) Limited come from?
All FDA import refusal data for Organon (India) Limited 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.