ImportRefusal LogoImportRefusal

PRODUCTOS MAVER S.A. DE C.V.

⚠️ High Risk

FEI: 3017183776 • Tlaquepaque • MEXICO

FEI

FEI Number

3017183776

📍

Location

Tlaquepaque

🇲🇽

Country

MEXICO
🏢

Address

No 520 Interior 6 Carre, , Tlaquepaque, , Mexico

High Risk

FDA Import Risk Assessment

57.6
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

3
Total Refusals
1
Unique Violations
4/14/2025
Latest Refusal
11/30/2021
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
70.0×20%
Frequency
8.9×10%
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
4/14/2025
56BCY03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
Division of Southeast Imports (DSEI)
5/1/2024
56BDA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
Division of Southeast Imports (DSEI)
11/30/2021
62VCA01AMANTADINE HCL (ANTI-VIRAL)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is PRODUCTOS MAVER S.A. DE C.V.'s FDA import refusal history?

PRODUCTOS MAVER S.A. DE C.V. (FEI: 3017183776) has 3 FDA import refusal record(s) in our database, spanning from 11/30/2021 to 4/14/2025.

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. PRODUCTOS MAVER S.A. DE C.V.'s FEI number is 3017183776.

What types of violations has PRODUCTOS MAVER S.A. DE C.V. received?

PRODUCTOS MAVER 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 PRODUCTOS MAVER S.A. DE C.V. come from?

All FDA import refusal data for PRODUCTOS MAVER 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.