Sun Biotechnology Ltd
⚠️ High Risk
FEI: 3003435391 • Calcutta • INDIA
FEI Number
3003435391
Location
Calcutta
Country
INDIAAddress
21a Shakespeare Sarani, , Calcutta, , India
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
SALMONELLA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Salmonella, a poisonous and deleterious substance which may render it injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/5/2004 | 16XGD21SHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS | 249FILTHY | Los Angeles District Office (LOS-DO) |
| 3/5/2004 | 16XGD21SHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS | 249FILTHY | Los Angeles District Office (LOS-DO) |
| 3/5/2004 | 16XGD21SHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS | 249FILTHY | Los Angeles District Office (LOS-DO) |
| 8/7/2003 | 16JFD05SHRIMP & PRAWNS | Detroit District Office (DET-DO) | |
| 8/7/2003 | 16JFD05SHRIMP & PRAWNS | Detroit District Office (DET-DO) | |
| 7/15/2003 | 16JFD05SHRIMP & PRAWNS | Detroit District Office (DET-DO) | |
| 4/29/2003 | 16JGT05SHRIMP & PRAWNS | 249FILTHY | Los Angeles District Office (LOS-DO) |
| 3/26/2003 | 16JGT05SHRIMP & PRAWNS | 249FILTHY | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Sun Biotechnology Ltd's FDA import refusal history?
Sun Biotechnology Ltd (FEI: 3003435391) has 8 FDA import refusal record(s) in our database, spanning from 3/26/2003 to 3/5/2004.
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. Sun Biotechnology Ltd's FEI number is 3003435391.
What types of violations has Sun Biotechnology Ltd received?
Sun Biotechnology Ltd 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 Sun Biotechnology Ltd come from?
All FDA import refusal data for Sun Biotechnology Ltd 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.