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ENAT INTERNATIONAL S.A. de C.V.

⚠️ Moderate Risk

FEI: 3009341057 • Salamanca, Guanajuato • MEXICO

FEI

FEI Number

3009341057

📍

Location

Salamanca, Guanajuato

🇲🇽

Country

MEXICO
🏢

Address

Carretera Federal Tramo Salamanca-Irapuato Km 320 Interior B, , Salamanca, Guanajuato, Mexico

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
11/29/2012
Latest Refusal
11/29/2012
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

751×

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
11/29/2012
20UGO06PRICKLE PEAR CACTUS - EDIBLE STEMS OR PADS (CORE FRUIT PUREES)
75UNAPPROVED
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is ENAT INTERNATIONAL S.A. de C.V.'s FDA import refusal history?

ENAT INTERNATIONAL S.A. de C.V. (FEI: 3009341057) has 1 FDA import refusal record(s) in our database, spanning from 11/29/2012 to 11/29/2012.

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. ENAT INTERNATIONAL S.A. de C.V.'s FEI number is 3009341057.

What types of violations has ENAT INTERNATIONAL S.A. de C.V. received?

ENAT INTERNATIONAL S.A. de C.V. 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 ENAT INTERNATIONAL S.A. de C.V. come from?

All FDA import refusal data for ENAT INTERNATIONAL S.A. de C.V. 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.