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C.AL.C.A.R (Cooperativa Agraria Limitada Carmelo)

⚠️ Moderate Risk

FEI: 3004259772 • Carmelo, Colonia • URUGUAY

FEI

FEI Number

3004259772

📍

Location

Carmelo, Colonia

🇺🇾

Country

URUGUAY
🏢

Address

Ruta 21, Km 251. 500, , Carmelo, Colonia, Uruguay

Moderate Risk

FDA Import Risk Assessment

43.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
2
Unique Violations
4/3/2015
Latest Refusal
4/3/2015
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

© ImportRefusal.com Original Analysis

Violation Summary

624×

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).

834×

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

DateProductViolationsDivision
4/3/2015
14AFS02FILLED MILK, FLUID CREAM TYPE PRODUCT
62NEEDS FCE
83NO PROCESS
New Orleans District Office (NOL-DO)
4/3/2015
14AFS02FILLED MILK, FLUID CREAM TYPE PRODUCT
62NEEDS FCE
83NO PROCESS
New Orleans District Office (NOL-DO)
4/3/2015
14AFS02FILLED MILK, FLUID CREAM TYPE PRODUCT
62NEEDS FCE
83NO PROCESS
New Orleans District Office (NOL-DO)
4/3/2015
14AFS02FILLED MILK, FLUID CREAM TYPE PRODUCT
62NEEDS FCE
83NO PROCESS
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is C.AL.C.A.R (Cooperativa Agraria Limitada Carmelo)'s FDA import refusal history?

C.AL.C.A.R (Cooperativa Agraria Limitada Carmelo) (FEI: 3004259772) has 4 FDA import refusal record(s) in our database, spanning from 4/3/2015 to 4/3/2015.

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. C.AL.C.A.R (Cooperativa Agraria Limitada Carmelo)'s FEI number is 3004259772.

What types of violations has C.AL.C.A.R (Cooperativa Agraria Limitada Carmelo) received?

C.AL.C.A.R (Cooperativa Agraria Limitada Carmelo) 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 C.AL.C.A.R (Cooperativa Agraria Limitada Carmelo) come from?

All FDA import refusal data for C.AL.C.A.R (Cooperativa Agraria Limitada Carmelo) 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.