Rauachandran
⚠️ Moderate Risk
FEI: 3008377676 • Mudarai • INDIA
FEI Number
3008377676
Location
Mudarai
Country
INDIAAddress
No 5 Vital Krupa 1 Thirvanga Post, , Mudarai, , 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 |
|---|---|---|---|
| 7/28/2010 | 60SCA27RABEPRAZOLE SODIUM (ANTACID) (ANTI-ULCER) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/28/2010 | 61JCA09FENOFIBRATE (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/28/2010 | 61JCA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/28/2010 | 62OCA37IRBESARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Rauachandran's FDA import refusal history?
Rauachandran (FEI: 3008377676) has 4 FDA import refusal record(s) in our database, spanning from 7/28/2010 to 7/28/2010.
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. Rauachandran's FEI number is 3008377676.
What types of violations has Rauachandran received?
Rauachandran 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 Rauachandran come from?
All FDA import refusal data for Rauachandran 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.