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Envios Empaques Sa De Cv

⚠️ Moderate Risk

FEI: 3008522637 • Tlalpantlalpan • MEXICO

FEI

FEI Number

3008522637

📍

Location

Tlalpantlalpan

🇲🇽

Country

MEXICO
🏢

Address

Prol Division Del Norte 706 Aprado Coapa, , Tlalpantlalpan, , Mexico

Moderate Risk

FDA Import Risk Assessment

45.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
11/29/2010
Latest Refusal
11/29/2010
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

753×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
11/29/2010
66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
11/29/2010
60WCY16MEBENDAZOLE (ANTHELMINTIC)
75UNAPPROVED
Cincinnati District Office (CIN-DO)
11/29/2010
56OYY01LEVAQUIN (FLUOROQUINOLONE)
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Envios Empaques Sa De Cv's FDA import refusal history?

Envios Empaques Sa De Cv (FEI: 3008522637) has 3 FDA import refusal record(s) in our database, spanning from 11/29/2010 to 11/29/2010.

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. Envios Empaques Sa De Cv's FEI number is 3008522637.

What types of violations has Envios Empaques Sa De Cv received?

Envios Empaques 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 Envios Empaques Sa De Cv come from?

All FDA import refusal data for Envios Empaques 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.