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BY MAYOLY SPINDLER DE MEXICO SA

⚠️ Moderate Risk

FEI: 3022358625 • Cuautitlan • MEXICO

FEI

FEI Number

3022358625

📍

Location

Cuautitlan

🇲🇽

Country

MEXICO
🏢

Address

Av Tejocotes Sn Agave 1, , Cuautitlan, , 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
54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is BY MAYOLY SPINDLER DE MEXICO SA's FDA import refusal history?

BY MAYOLY SPINDLER DE MEXICO SA (FEI: 3022358625) 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. BY MAYOLY SPINDLER DE MEXICO SA's FEI number is 3022358625.

What types of violations has BY MAYOLY SPINDLER DE MEXICO SA received?

BY MAYOLY SPINDLER DE MEXICO SA 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 BY MAYOLY SPINDLER DE MEXICO SA come from?

All FDA import refusal data for BY MAYOLY SPINDLER DE MEXICO SA 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.