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MAYOLY SPINDLER DE MEXICO S.A DE

⚠️ Moderate Risk

FEI: 3022358622 • San Martin Obispo • MEXICO

FEI

FEI Number

3022358622

📍

Location

San Martin Obispo

🇲🇽

Country

MEXICO
🏢

Address

Av. Tejocotes S/N Agave, , San Martin Obispo, , Mexico

Moderate Risk

FDA Import Risk Assessment

43.1
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
6/2/2022
Latest Refusal
6/2/2022
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
13.7×20%
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
6/2/2022
61KCE01ALVERINE CITRATE (ANTI-CHOLINERGIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is MAYOLY SPINDLER DE MEXICO S.A DE's FDA import refusal history?

MAYOLY SPINDLER DE MEXICO S.A DE (FEI: 3022358622) has 1 FDA import refusal record(s) in our database, spanning from 6/2/2022 to 6/2/2022.

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. MAYOLY SPINDLER DE MEXICO S.A DE's FEI number is 3022358622.

What types of violations has MAYOLY SPINDLER DE MEXICO S.A DE received?

MAYOLY SPINDLER DE MEXICO S.A DE 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 MAYOLY SPINDLER DE MEXICO S.A DE come from?

All FDA import refusal data for MAYOLY SPINDLER DE MEXICO S.A DE 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.