DISTRIBUIDORA LUCEMA SA
⚠️ Moderate Risk
FEI: 3013445797 • Santa Ana, San Jose • COSTA RICA
FEI Number
3013445797
Location
Santa Ana, San Jose
Country
COSTA RICAAddress
Apdo 4772 2.5 Km Oestede Forum # 1, , Santa Ana, San Jose, Costa Rica
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
Frequently Asked Questions
What is DISTRIBUIDORA LUCEMA SA's FDA import refusal history?
DISTRIBUIDORA LUCEMA SA (FEI: 3013445797) has 1 FDA import refusal record(s) in our database, spanning from 11/30/2017 to 11/30/2017.
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. DISTRIBUIDORA LUCEMA SA's FEI number is 3013445797.
What types of violations has DISTRIBUIDORA LUCEMA SA received?
DISTRIBUIDORA LUCEMA SA 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 LUCEMA SA come from?
All FDA import refusal data for DISTRIBUIDORA LUCEMA SA 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.