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Procesadora de Moles y Derivados Monarca

⚠️ Moderate Risk

FEI: 3004272727 • Mexico, Distrito Federal • MEXICO

FEI

FEI Number

3004272727

📍

Location

Mexico, Distrito Federal

🇲🇽

Country

MEXICO
🏢

Address

Manto No. 13 Cololnia Cuauhtemoc, Magdalena Contreras, Mexico, Distrito Federal, Mexico

Moderate Risk

FDA Import Risk Assessment

39.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
12/15/2009
Latest Refusal
12/15/2009
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

622×

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).

832×

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
12/15/2009
37KCT18MOLE PASTE
62NEEDS FCE
83NO PROCESS
Southwest Import District Office (SWI-DO)
12/15/2009
37KCT18MOLE PASTE
62NEEDS FCE
83NO PROCESS
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Procesadora de Moles y Derivados Monarca's FDA import refusal history?

Procesadora de Moles y Derivados Monarca (FEI: 3004272727) has 2 FDA import refusal record(s) in our database, spanning from 12/15/2009 to 12/15/2009.

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. Procesadora de Moles y Derivados Monarca's FEI number is 3004272727.

What types of violations has Procesadora de Moles y Derivados Monarca received?

Procesadora de Moles y Derivados Monarca 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 Procesadora de Moles y Derivados Monarca come from?

All FDA import refusal data for Procesadora de Moles y Derivados Monarca 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.