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DDI MULTINACIONAL SA DE CV

⚠️ Moderate Risk

FEI: 3012510709 • Iztapalapa • MEXICO

FEI

FEI Number

3012510709

📍

Location

Iztapalapa

🇲🇽

Country

MEXICO
🏢

Address

Javier Espinoza Mz. 30, Lt. 20 Santa Martha Acatitla, , Iztapalapa, , Mexico

Moderate Risk

FDA Import Risk Assessment

45.6
LowModerateHighCritical

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

Statistics

5
Total Refusals
1
Unique Violations
2/18/2021
Latest Refusal
9/9/2020
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

275×

DRUG GMPS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).

Refusal History

DateProductViolationsDivision
2/18/2021
62HBY05ETHYL ALCOHOL (ANTI-MICROBIAL)
27DRUG GMPS
Division of Southwest Imports (DSWI)
2/12/2021
62HBY05ETHYL ALCOHOL (ANTI-MICROBIAL)
27DRUG GMPS
Division of Southwest Imports (DSWI)
1/23/2021
62HBY05ETHYL ALCOHOL (ANTI-MICROBIAL)
27DRUG GMPS
Division of Southwest Imports (DSWI)
1/22/2021
62HBY05ETHYL ALCOHOL (ANTI-MICROBIAL)
27DRUG GMPS
Division of Southwest Imports (DSWI)
9/9/2020
62HBK05ETHYL ALCOHOL (ANTI-MICROBIAL)
27DRUG GMPS
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is DDI MULTINACIONAL SA DE CV's FDA import refusal history?

DDI MULTINACIONAL SA DE CV (FEI: 3012510709) has 5 FDA import refusal record(s) in our database, spanning from 9/9/2020 to 2/18/2021.

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. DDI MULTINACIONAL SA DE CV's FEI number is 3012510709.

What types of violations has DDI MULTINACIONAL SA DE CV received?

DDI MULTINACIONAL SA DE CV has been cited for 1 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 DDI MULTINACIONAL SA DE CV come from?

All FDA import refusal data for DDI MULTINACIONAL SA DE CV 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.