ImportRefusal LogoImportRefusal

CareFusion 213, LLC

⚠️ Moderate Risk

FEI: 3004932373 • El Paso, TX • UNITED STATES

FEI

FEI Number

3004932373

📍

Location

El Paso, TX

🇺🇸
🏢

Address

1550 Northwestern Dr, , El Paso, TX, United States

Moderate Risk

FDA Import Risk Assessment

45.7
LowModerateHighCritical

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

Statistics

25
Total Refusals
3
Unique Violations
8/10/2011
Latest Refusal
5/24/2009
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
52.4×30%
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

11824×

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).

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

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
8/10/2011
62HBL99ANTI-MICROBIAL N.E.C.
118NOT LISTED
Southwest Import District Office (SWI-DO)
8/10/2011
62HBL99ANTI-MICROBIAL N.E.C.
118NOT LISTED
Southwest Import District Office (SWI-DO)
8/10/2011
62HBL99ANTI-MICROBIAL N.E.C.
118NOT LISTED
Southwest Import District Office (SWI-DO)
8/10/2011
62HBL99ANTI-MICROBIAL N.E.C.
118NOT LISTED
Southwest Import District Office (SWI-DO)
8/10/2011
62HBL99ANTI-MICROBIAL N.E.C.
118NOT LISTED
Southwest Import District Office (SWI-DO)
8/10/2011
62HBL99ANTI-MICROBIAL N.E.C.
118NOT LISTED
Southwest Import District Office (SWI-DO)
8/10/2011
62HBL99ANTI-MICROBIAL N.E.C.
118NOT LISTED
Southwest Import District Office (SWI-DO)
8/10/2011
62HBL99ANTI-MICROBIAL N.E.C.
118NOT LISTED
Southwest Import District Office (SWI-DO)
8/10/2011
62HBL99ANTI-MICROBIAL N.E.C.
118NOT LISTED
Southwest Import District Office (SWI-DO)
8/10/2011
62HBL99ANTI-MICROBIAL N.E.C.
118NOT LISTED
Southwest Import District Office (SWI-DO)
8/10/2011
62HBL99ANTI-MICROBIAL N.E.C.
118NOT LISTED
Southwest Import District Office (SWI-DO)
8/10/2011
62HBL99ANTI-MICROBIAL N.E.C.
118NOT LISTED
Southwest Import District Office (SWI-DO)
8/10/2011
62HBL99ANTI-MICROBIAL N.E.C.
118NOT LISTED
Southwest Import District Office (SWI-DO)
8/10/2011
62HBL99ANTI-MICROBIAL N.E.C.
118NOT LISTED
Southwest Import District Office (SWI-DO)
8/10/2011
62HBL99ANTI-MICROBIAL N.E.C.
118NOT LISTED
Southwest Import District Office (SWI-DO)
8/10/2011
62HBL99ANTI-MICROBIAL N.E.C.
118NOT LISTED
Southwest Import District Office (SWI-DO)
6/21/2011
62HBL99ANTI-MICROBIAL N.E.C.
118NOT LISTED
Southwest Import District Office (SWI-DO)
6/21/2011
62HBL99ANTI-MICROBIAL N.E.C.
118NOT LISTED
Southwest Import District Office (SWI-DO)
6/21/2011
62HBL99ANTI-MICROBIAL N.E.C.
118NOT LISTED
Southwest Import District Office (SWI-DO)
6/21/2011
62HBL99ANTI-MICROBIAL N.E.C.
118NOT LISTED
Southwest Import District Office (SWI-DO)
6/8/2011
62HBL99ANTI-MICROBIAL N.E.C.
118NOT LISTED
Southwest Import District Office (SWI-DO)
6/8/2011
62HBL99ANTI-MICROBIAL N.E.C.
118NOT LISTED
Southwest Import District Office (SWI-DO)
6/8/2011
62HBL99ANTI-MICROBIAL N.E.C.
118NOT LISTED
Southwest Import District Office (SWI-DO)
6/8/2011
62HBL99ANTI-MICROBIAL N.E.C.
118NOT LISTED
Southwest Import District Office (SWI-DO)
5/24/2009
73CBKVENTILATOR, CONTINUOUS (RESPIRATOR)
341REGISTERED
508NO 510(K)
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is CareFusion 213, LLC's FDA import refusal history?

CareFusion 213, LLC (FEI: 3004932373) has 25 FDA import refusal record(s) in our database, spanning from 5/24/2009 to 8/10/2011.

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. CareFusion 213, LLC's FEI number is 3004932373.

What types of violations has CareFusion 213, LLC received?

CareFusion 213, LLC has been cited for 3 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 CareFusion 213, LLC come from?

All FDA import refusal data for CareFusion 213, LLC 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.