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Sofi de Chihuahua S.A. de C.V.

⚠️ Moderate Risk

FEI: 3003291784 • Chihuahua, CHI • MEXICO

FEI

FEI Number

3003291784

📍

Location

Chihuahua, CHI

🇲🇽

Country

MEXICO
🏢

Address

Calle Washington No. 3701,, Int. Ave. de las Americas Edif. 10 y 11, Chihuahua, CHI, Mexico

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
3/22/2017
Latest Refusal
3/22/2017
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

2351×

NOT IMPACT

The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.

Refusal History

DateProductViolationsDivision
3/22/2017
86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
235NOT IMPACT
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Sofi de Chihuahua S.A. de C.V.'s FDA import refusal history?

Sofi de Chihuahua S.A. de C.V. (FEI: 3003291784) has 1 FDA import refusal record(s) in our database, spanning from 3/22/2017 to 3/22/2017.

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. Sofi de Chihuahua S.A. de C.V.'s FEI number is 3003291784.

What types of violations has Sofi de Chihuahua S.A. de C.V. received?

Sofi de Chihuahua S.A. de C.V. 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 Sofi de Chihuahua S.A. de C.V. come from?

All FDA import refusal data for Sofi de Chihuahua S.A. de C.V. 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.