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Becton Dickinson Caribe LTD

⚠️ Moderate Risk

FEI: 2649711 • Juncos, PR • UNITED STATES

FEI

FEI Number

2649711

📍

Location

Juncos, PR

🇺🇸
🏢

Address

Road 31, Km 24.3, , Juncos, PR, United States

Moderate Risk

FDA Import Risk Assessment

35.1
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
2/2/2023
Latest Refusal
2/25/2022
Earliest Refusal

Score Breakdown

Violation Severity
56.7×40%
Refusal Volume
17.7×30%
Recency
25.9×20%
Frequency
20.0×10%
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

1182×

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).

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
2/2/2023
75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
118NOT LISTED
Division of Southeast Imports (DSEI)
2/25/2022
73BSPNEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
118NOT LISTED
508NO 510(K)
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Becton Dickinson Caribe LTD's FDA import refusal history?

Becton Dickinson Caribe LTD (FEI: 2649711) has 2 FDA import refusal record(s) in our database, spanning from 2/25/2022 to 2/2/2023.

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. Becton Dickinson Caribe LTD's FEI number is 2649711.

What types of violations has Becton Dickinson Caribe LTD received?

Becton Dickinson Caribe LTD 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 Becton Dickinson Caribe LTD come from?

All FDA import refusal data for Becton Dickinson Caribe LTD 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.