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ARMANDO SANCHEZ DE JESUS

Low Risk

FEI: 3015429960 • Pittsburg, CA • UNITED STATES

FEI

FEI Number

3015429960

📍

Location

Pittsburg, CA

🇺🇸
🏢

Address

77 Bruno Ave, , Pittsburg, CA, United States

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
8/9/2019
Latest Refusal
8/9/2019
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
8/9/2019
89IRAHAND, EXTERNAL LIMB COMPONENT, MECHANICAL
118NOT LISTED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is ARMANDO SANCHEZ DE JESUS's FDA import refusal history?

ARMANDO SANCHEZ DE JESUS (FEI: 3015429960) has 1 FDA import refusal record(s) in our database, spanning from 8/9/2019 to 8/9/2019.

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. ARMANDO SANCHEZ DE JESUS's FEI number is 3015429960.

What types of violations has ARMANDO SANCHEZ DE JESUS received?

ARMANDO SANCHEZ DE JESUS 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 ARMANDO SANCHEZ DE JESUS come from?

All FDA import refusal data for ARMANDO SANCHEZ DE JESUS 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.