Synthite Exports Private Limited
⚠️ Moderate Risk
FEI: 2000036207 • Cochin, Kerala • INDIA
FEI Number
2000036207
Location
Cochin, Kerala
Country
INDIAAddress
Ajay Vihar, M.G Road, Ernakulam District, Cochin, Kerala, 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
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.
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.
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 |
|---|---|---|---|
| 3/30/2017 | 28OEE99ESSENTIAL OILS FOR FLAVORING, N.E.C. | 249FILTHY | New Orleans District Office (NOL-DO) |
| 7/9/2012 | 54YCT99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/23/2010 | 28BGH54PEPPER, BLACK, GROUND, CRACKED (SPICE) | 9SALMONELLA | Cincinnati District Office (CIN-DO) |
| 9/23/2010 | 28BGH54PEPPER, BLACK, GROUND, CRACKED (SPICE) | 9SALMONELLA | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Synthite Exports Private Limited's FDA import refusal history?
Synthite Exports Private Limited (FEI: 2000036207) has 4 FDA import refusal record(s) in our database, spanning from 9/23/2010 to 3/30/2017.
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. Synthite Exports Private Limited's FEI number is 2000036207.
What types of violations has Synthite Exports Private Limited received?
Synthite Exports Private Limited has been cited for 3 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 Synthite Exports Private Limited come from?
All FDA import refusal data for Synthite Exports Private 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.