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Operadora Pm Sa De Cv

⚠️ Moderate Risk

FEI: 3003549866 • Col La Otra Banda • MEXICO

FEI

FEI Number

3003549866

📍

Location

Col La Otra Banda

🇲🇽

Country

MEXICO
🏢

Address

Av San Jeronimo #630, , Col La Otra Banda, , Mexico

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
2/25/2002
Latest Refusal
2/25/2002
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

841×

RX DEVICE

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.

Refusal History

DateProductViolationsDivision
2/25/2002
86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
84RX DEVICE
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Operadora Pm Sa De Cv's FDA import refusal history?

Operadora Pm Sa De Cv (FEI: 3003549866) has 1 FDA import refusal record(s) in our database, spanning from 2/25/2002 to 2/25/2002.

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. Operadora Pm Sa De Cv's FEI number is 3003549866.

What types of violations has Operadora Pm Sa De Cv received?

Operadora Pm Sa De Cv 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 Operadora Pm Sa De Cv come from?

All FDA import refusal data for Operadora Pm 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.