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Bard Reynosa S.A. De C.V.

⚠️ High Risk

FEI: 3002468371 • Reynosa, Tamaulipas • MEXICO

FEI

FEI Number

3002468371

📍

Location

Reynosa, Tamaulipas

🇲🇽

Country

MEXICO
🏢

Address

Calle Monte Bello 1, Col. CASA BELLA, Reynosa, Tamaulipas, Mexico

High Risk

FDA Import Risk Assessment

51.6
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

19
Total Refusals
2
Unique Violations
5/4/2009
Latest Refusal
6/24/2008
Earliest Refusal

Score Breakdown

Violation Severity
67.9×40%
Refusal Volume
48.2×30%
Recency
0.0×20%
Frequency
100.0×10%
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

334014×

DE/RX KIT

The article appears to be a combination medical device/prescription drug kit for which the prescription drug component was manufactured in the U.S., is offered for import by other than the manufacturer, and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.

755×

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
5/4/2009
80LJSCATHETER, PERCUTANEOUS, INTRAVASCULAR, LONG TERM
3340DE/RX KIT
Southwest Import District Office (SWI-DO)
5/4/2009
80LJSCATHETER, PERCUTANEOUS, INTRAVASCULAR, LONG TERM
3340DE/RX KIT
Southwest Import District Office (SWI-DO)
8/18/2008
80LJSCATHETER, PERCUTANEOUS, INTRAVASCULAR, LONG TERM
75UNAPPROVED
Southwest Import District Office (SWI-DO)
8/18/2008
78MSDCATHETER, HEMODIALYSIS, IMPLANTED
75UNAPPROVED
Southwest Import District Office (SWI-DO)
8/18/2008
80LJSCATHETER, PERCUTANEOUS, INTRAVASCULAR, LONG TERM
75UNAPPROVED
Southwest Import District Office (SWI-DO)
8/18/2008
80LJSCATHETER, PERCUTANEOUS, INTRAVASCULAR, LONG TERM
75UNAPPROVED
Southwest Import District Office (SWI-DO)
8/18/2008
80LJSCATHETER, PERCUTANEOUS, INTRAVASCULAR, LONG TERM
75UNAPPROVED
Southwest Import District Office (SWI-DO)
7/22/2008
80LJSCATHETER, PERCUTANEOUS, INTRAVASCULAR, LONG TERM
3340DE/RX KIT
Southwest Import District Office (SWI-DO)
7/22/2008
80LJSCATHETER, PERCUTANEOUS, INTRAVASCULAR, LONG TERM
3340DE/RX KIT
Southwest Import District Office (SWI-DO)
7/22/2008
80LJSCATHETER, PERCUTANEOUS, INTRAVASCULAR, LONG TERM
3340DE/RX KIT
Southwest Import District Office (SWI-DO)
7/22/2008
80LJSCATHETER, PERCUTANEOUS, INTRAVASCULAR, LONG TERM
3340DE/RX KIT
Southwest Import District Office (SWI-DO)
6/24/2008
80LJSCATHETER, PERCUTANEOUS, INTRAVASCULAR, LONG TERM
3340DE/RX KIT
Southwest Import District Office (SWI-DO)
6/24/2008
80LJSCATHETER, PERCUTANEOUS, INTRAVASCULAR, LONG TERM
3340DE/RX KIT
Southwest Import District Office (SWI-DO)
6/24/2008
80LJSCATHETER, PERCUTANEOUS, INTRAVASCULAR, LONG TERM
3340DE/RX KIT
Southwest Import District Office (SWI-DO)
6/24/2008
80LJSCATHETER, PERCUTANEOUS, INTRAVASCULAR, LONG TERM
3340DE/RX KIT
Southwest Import District Office (SWI-DO)
6/24/2008
80LJSCATHETER, PERCUTANEOUS, INTRAVASCULAR, LONG TERM
3340DE/RX KIT
Southwest Import District Office (SWI-DO)
6/24/2008
80LJSCATHETER, PERCUTANEOUS, INTRAVASCULAR, LONG TERM
3340DE/RX KIT
Southwest Import District Office (SWI-DO)
6/24/2008
80LJSCATHETER, PERCUTANEOUS, INTRAVASCULAR, LONG TERM
3340DE/RX KIT
Southwest Import District Office (SWI-DO)
6/24/2008
80LJSCATHETER, PERCUTANEOUS, INTRAVASCULAR, LONG TERM
3340DE/RX KIT
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Bard Reynosa S.A. De C.V.'s FDA import refusal history?

Bard Reynosa S.A. De C.V. (FEI: 3002468371) has 19 FDA import refusal record(s) in our database, spanning from 6/24/2008 to 5/4/2009.

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. Bard Reynosa S.A. De C.V.'s FEI number is 3002468371.

What types of violations has Bard Reynosa S.A. De C.V. received?

Bard Reynosa S.A. De C.V. 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 Bard Reynosa S.A. De C.V. come from?

All FDA import refusal data for Bard 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.