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ERIKA DE REYNOSA, S.A. DE C.V.

⚠️ Moderate Risk

FEI: 3002807744 • Reynosa, Tamaulipas • MEXICO

FEI

FEI Number

3002807744

📍

Location

Reynosa, Tamaulipas

🇲🇽

Country

MEXICO
🏢

Address

Mike Allen 1331, Zona Industrial Parque Industrial Center, Reynosa, Reynosa, Tamaulipas, Mexico

Moderate Risk

FDA Import Risk Assessment

35.2
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
2/23/2011
Latest Refusal
2/9/2010
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
19.3×10%
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

4792×

DV QUALITY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.

Refusal History

DateProductViolationsDivision
2/23/2011
78FJKSET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
479DV QUALITY
Southwest Import District Office (SWI-DO)
2/9/2010
78FJKSET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
479DV QUALITY
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is ERIKA DE REYNOSA, S.A. DE C.V.'s FDA import refusal history?

ERIKA DE REYNOSA, S.A. DE C.V. (FEI: 3002807744) has 2 FDA import refusal record(s) in our database, spanning from 2/9/2010 to 2/23/2011.

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. ERIKA DE REYNOSA, S.A. DE C.V.'s FEI number is 3002807744.

What types of violations has ERIKA DE REYNOSA, S.A. DE C.V. received?

ERIKA DE REYNOSA, 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 ERIKA DE REYNOSA, S.A. DE C.V. come from?

All FDA import refusal data for ERIKA DE REYNOSA, 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.