Sandu Pharmaceutical
✅ Low Risk
FEI: 3008493347 • Mumbai • INDIA
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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
FALSE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/26/2012 | 54FGT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 260FALSE | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Sandu Pharmaceutical's FDA import refusal history?
Sandu Pharmaceutical (FEI: 3008493347) has 1 FDA import refusal record(s) in our database, spanning from 6/26/2012 to 6/26/2012.
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. Sandu Pharmaceutical's FEI number is 3008493347.
What types of violations has Sandu Pharmaceutical received?
Sandu Pharmaceutical 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 Sandu Pharmaceutical come from?
All FDA import refusal data for Sandu Pharmaceutical 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.