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PRODUCTOS MAVER SA DE CV

⚠️ High Risk

FEI: 3039590767 • Morelia, Michoacan de Ocampo • MEXICO

FEI

FEI Number

3039590767

📍

Location

Morelia, Michoacan de Ocampo

🇲🇽

Country

MEXICO
🏢

Address

Calle Jose S. Aceves 140 Pr, Col. Congreso Constituyente De Michoacan, Morelia, Morelia, Michoacan de Ocampo, Mexico

High Risk

FDA Import Risk Assessment

51.2
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
9/29/2025
Latest Refusal
9/29/2025
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
94.2×20%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

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
9/29/2025
62ODA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II)
118NOT LISTED
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is PRODUCTOS MAVER SA DE CV's FDA import refusal history?

PRODUCTOS MAVER SA DE CV (FEI: 3039590767) has 1 FDA import refusal record(s) in our database, spanning from 9/29/2025 to 9/29/2025.

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 SA DE CV's FEI number is 3039590767.

What types of violations has PRODUCTOS MAVER SA DE CV received?

PRODUCTOS MAVER SA DE CV 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 PRODUCTOS MAVER SA DE CV come from?

All FDA import refusal data for PRODUCTOS MAVER 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.