Grupo Litoral S.A.
⚠️ Moderate Risk
FEI: 3003398267 • San Andress • COLOMBIA
FEI Number
3003398267
Location
San Andress
Country
COLOMBIAAddress
Ave Nixon Hill Cantera, , San Andress, , Colombia
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
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/2/2003 | 24AET54FIELD PEA (SMOOTH), CROWDER, WHITE PEAS | Florida District Office (FLA-DO) | |
| 1/2/2003 | 25EET02CARROTS AND PEAS (SWEET) (MIXED VEGETABLES) | Florida District Office (FLA-DO) | |
| 1/2/2003 | 16CET07BONITO, CAKES, BALLS, ETC. | Florida District Office (FLA-DO) | |
| 1/2/2003 | 38YET99SOUP, N.E.C. | Florida District Office (FLA-DO) | |
| 11/19/2001 | 09CEE99MILK AND CREAM, N.E.C. | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Grupo Litoral S.A.'s FDA import refusal history?
Grupo Litoral S.A. (FEI: 3003398267) has 5 FDA import refusal record(s) in our database, spanning from 11/19/2001 to 1/2/2003.
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. Grupo Litoral S.A.'s FEI number is 3003398267.
What types of violations has Grupo Litoral S.A. received?
Grupo Litoral S.A. 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 Grupo Litoral S.A. come from?
All FDA import refusal data for Grupo Litoral S.A. 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.