PROVISIONES MACEDONIA

⚠️ Moderate Risk

FEI: 3004296232 • Medellin, Antioquia • COLOMBIA

FEI

FEI Number

3004296232

📍

Location

Medellin, Antioquia

🇨🇴

Country

COLOMBIA

🏢

Address

Calle 60 43 37, , Medellin, Antioquia, Colombia

Moderate Risk

FDA Import Risk Assessment

47.4

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

8/31/2004

Latest Refusal

8/31/2004

Earliest Refusal

Score Breakdown

Violation Severity

80.0×40%

Refusal Volume

31.3×30%

Recency

0.0×20%

Frequency

60.0×10%

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

Violation Summary

626×

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).

835×

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
8/31/2004	24VCN02ASPARAGUS, WITH SAUCE	62NEEDS FCE 83NO PROCESS	Florida District Office (FLA-DO)
8/31/2004	27ACE03SALAD DRESSING, STANDARDIZED	62NEEDS FCE 83NO PROCESS	Florida District Office (FLA-DO)
8/31/2004	25HCN99MIXED VEGETABLES, WITH SAUCE, N.E.C.	62NEEDS FCE 83NO PROCESS	Florida District Office (FLA-DO)
8/31/2004	05BEN01CORN GRITS, BREWERS ENRICHED WHITE OR YELLOW CORN GRITS,CORN MEAL MUSH, QUICK OR INSTANT COOKING	62NEEDS FCE 83NO PROCESS	Florida District Office (FLA-DO)
8/31/2004	37JCE05SOY SAUCE	62NEEDS FCE 83NO PROCESS	Florida District Office (FLA-DO)
8/31/2004	24AEN14STRINGBEANS	62NEEDS FCE	Florida District Office (FLA-DO)

Frequently Asked Questions

What is PROVISIONES MACEDONIA's FDA import refusal history?

PROVISIONES MACEDONIA (FEI: 3004296232) has 6 FDA import refusal record(s) in our database, spanning from 8/31/2004 to 8/31/2004.

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. PROVISIONES MACEDONIA's FEI number is 3004296232.

What types of violations has PROVISIONES MACEDONIA received?

PROVISIONES MACEDONIA 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 PROVISIONES MACEDONIA come from?

All FDA import refusal data for PROVISIONES MACEDONIA 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.