Ranbaxy Laboratories Limited
⚠️ Moderate Risk
FEI: 3003388833 • Ponda, Goa • INDIA
FEI Number
3003388833
Location
Ponda, Goa
Country
INDIAAddress
B - 2 Marcaim Industrial Estate, Plot No, Ponda, Goa, 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 |
|---|---|---|---|
| 10/22/2019 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/9/2011 | 61PCB99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/9/2011 | 61PCB99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/3/2008 | 62OBP29ENALAPRILATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/12/2004 | 65PCY02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/28/2004 | 65PCY02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Ranbaxy Laboratories Limited's FDA import refusal history?
Ranbaxy Laboratories Limited (FEI: 3003388833) has 6 FDA import refusal record(s) in our database, spanning from 5/28/2004 to 10/22/2019.
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. Ranbaxy Laboratories Limited's FEI number is 3003388833.
What types of violations has Ranbaxy Laboratories Limited received?
Ranbaxy Laboratories 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 Ranbaxy Laboratories Limited come from?
All FDA import refusal data for Ranbaxy Laboratories 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.