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Palm Computing Mexico Sa De Cv

⚠️ Moderate Risk

FEI: 3005919599 • Ciudad De Mexico, Ciudad de Mexico • MEXICO

FEI

FEI Number

3005919599

📍

Location

Ciudad De Mexico, Ciudad de Mexico

🇲🇽

Country

MEXICO
🏢

Address

Calle Montes Urales Norte 3er Pisolomas De 720, Col. Lomas De Chapultepec Iv Seccion, Miguel Hidalgo, Ciudad De Mexico, Ciudad de Mexico, Mexico

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/26/2006
Latest Refusal
10/26/2006
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

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
10/26/2006
64XAE11ISOTRETINOIN (KERATOLYTIC)
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Palm Computing Mexico Sa De Cv's FDA import refusal history?

Palm Computing Mexico Sa De Cv (FEI: 3005919599) has 1 FDA import refusal record(s) in our database, spanning from 10/26/2006 to 10/26/2006.

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. Palm Computing Mexico Sa De Cv's FEI number is 3005919599.

What types of violations has Palm Computing Mexico Sa De Cv received?

Palm Computing Mexico 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 Palm Computing Mexico Sa De Cv come from?

All FDA import refusal data for Palm Computing Mexico 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.