Distribuidora Cuscatleca
⚠️ Moderate Risk
FEI: 3005093954 • Antiguo Cuscatlan, La Libertad • EL SALVADOR
FEI Number
3005093954
Location
Antiguo Cuscatlan, La Libertad
Country
EL SALVADORAddress
Blvd Waltor Beinenger, , Antiguo Cuscatlan, La Libertad, El Salvador
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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/11/2007 | 41BGE99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS | 62NEEDS FCE | Atlanta District Office (ATL-DO) |
| 3/7/2006 | 56BCZ52PENCILLIN BENZATHINE SYNTHETIC PENICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 118NOT LISTED | Atlanta District Office (ATL-DO) |
Frequently Asked Questions
What is Distribuidora Cuscatleca's FDA import refusal history?
Distribuidora Cuscatleca (FEI: 3005093954) has 2 FDA import refusal record(s) in our database, spanning from 3/7/2006 to 4/11/2007.
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. Distribuidora Cuscatleca's FEI number is 3005093954.
What types of violations has Distribuidora Cuscatleca received?
Distribuidora Cuscatleca 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 Distribuidora Cuscatleca come from?
All FDA import refusal data for Distribuidora Cuscatleca 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.