Ranbaxy Inc.
⚠️ Moderate Risk
FEI: 3003476632 • Princeton, NJ • UNITED STATES
FEI Number
3003476632
Location
Princeton, NJ
Country
UNITED STATESAddress
600 College Rd E Ste 2100, , Princeton, NJ, United States
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
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
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 |
|---|---|---|---|
| 8/21/2009 | 61WDL23POTASSIUM IODIDE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 179AGR RX | Southwest Import District Office (SWI-DO) |
| 8/21/2009 | 62ODA34FOSINOPRIL SODIUM (ANTI-HYPERTENSIVE - PART II) | 179AGR RX | Southwest Import District Office (SWI-DO) |
| 8/21/2009 | 61HDH32NITROFURANTOIN (ANTI-BACTERIAL) | 179AGR RX | Southwest Import District Office (SWI-DO) |
| 5/27/2008 | 56YCB99ANTIBIOTIC N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/6/2007 | 56BYP03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 179AGR RX | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Ranbaxy Inc.'s FDA import refusal history?
Ranbaxy Inc. (FEI: 3003476632) has 5 FDA import refusal record(s) in our database, spanning from 2/6/2007 to 8/21/2009.
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 Inc.'s FEI number is 3003476632.
What types of violations has Ranbaxy Inc. received?
Ranbaxy Inc. 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 Ranbaxy Inc. come from?
All FDA import refusal data for Ranbaxy Inc. 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.