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BSN Medical SA de CV

⚠️ Moderate Risk

FEI: 3003255844 • Reynosa, Tamaulipas • MEXICO

FEI

FEI Number

3003255844

📍

Location

Reynosa, Tamaulipas

🇲🇽

Country

MEXICO
🏢

Address

Villa Florida, Ave De Los Encinos S/N Esq.. Ave; Av. Parque Sn, Reynosa, Tamaulipas, 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

7
Total Refusals
2
Unique Violations
1/23/2015
Latest Refusal
4/7/2003
Earliest Refusal

Score Breakdown

Violation Severity
44.3×40%
Refusal Volume
33.5×30%
Recency
0.0×20%
Frequency
5.9×10%
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

4845×

DV NAME

The article appears to be a device and its labeling fails to bear the proprietary or established name.

4722×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

Refusal History

DateProductViolationsDivision
1/23/2015
89IQKORTHOSIS, CERVICAL
484DV NAME
Southwest Import District Office (SWI-DO)
1/23/2015
79FYHSPLINT, EXTREMITY, NONINFLATABLE, EXTERNAL
484DV NAME
Southwest Import District Office (SWI-DO)
1/23/2015
89IQIORTHOSIS, LIMB BRACE
484DV NAME
Southwest Import District Office (SWI-DO)
1/23/2015
89IOYSUPPORT, ARM
484DV NAME
Southwest Import District Office (SWI-DO)
1/23/2015
89ITWJOINT, ANKLE, EXTERNAL BRACE
484DV NAME
Southwest Import District Office (SWI-DO)
4/7/2003
89ITGBANDAGE, CAST
472NO ENGLISH
Southwest Import District Office (SWI-DO)
4/7/2003
89ITGBANDAGE, CAST
472NO ENGLISH
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is BSN Medical SA de CV's FDA import refusal history?

BSN Medical SA de CV (FEI: 3003255844) has 7 FDA import refusal record(s) in our database, spanning from 4/7/2003 to 1/23/2015.

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. BSN Medical SA de CV's FEI number is 3003255844.

What types of violations has BSN Medical SA de CV received?

BSN Medical SA de CV has been cited for 2 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 BSN Medical SA de CV come from?

All FDA import refusal data for BSN Medical 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.