Cardinal Health (Kenmex Medical Specialties)
⚠️ Moderate Risk
FEI: 3002806934 • Tijuana, Baja California • MEXICO
FEI Number
3002806934
Location
Tijuana, Baja California
Country
MEXICOAddress
Calle 9 sur 1113, Ciudad Industrial, Tijuana, Baja California, Mexico
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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.
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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).
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/7/2019 | 80JOLCATHETER AND TIP, SUCTION | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 2/12/2019 | 78KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES) | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 11/21/2018 | 78KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES) | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 10/11/2018 | 80JOLCATHETER AND TIP, SUCTION | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 10/3/2018 | 80JOLCATHETER AND TIP, SUCTION | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 9/25/2017 | 80GAZTUBING, NONINVASIVE | Division of Northeast Imports (DNEI) | |
| 9/25/2017 | 80GCXAPPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED | Division of Northeast Imports (DNEI) | |
| 9/25/2017 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | Division of Northeast Imports (DNEI) | |
| 9/25/2017 | 79FZZMARKER, SKIN | Division of Northeast Imports (DNEI) | |
| 9/25/2017 | 80JOLCATHETER AND TIP, SUCTION | Division of Northeast Imports (DNEI) | |
| 9/25/2017 | 80GAZTUBING, NONINVASIVE | Division of Northeast Imports (DNEI) | |
| 9/25/2017 | 80FMHCONTAINER, SPECIMEN | Division of Northeast Imports (DNEI) | |
| 6/2/2017 | 78FPDTUBE, FEEDING | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 12/4/2014 | 74DRCTROCAR | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 5/29/2014 | 74DRCTROCAR | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 2/26/2014 | 78KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES) | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 1/31/2014 | 74DRCTROCAR | 126FAILS STD | Atlanta District Office (ATL-DO) |
| 1/31/2014 | 74DRCTROCAR | 126FAILS STD | Atlanta District Office (ATL-DO) |
| 1/31/2014 | 74DRCTROCAR | 126FAILS STD | Atlanta District Office (ATL-DO) |
| 1/31/2014 | 74DRCTROCAR | 126FAILS STD | Atlanta District Office (ATL-DO) |
| 1/31/2014 | 74DRCTROCAR | 126FAILS STD | Atlanta District Office (ATL-DO) |
| 1/31/2014 | 74DRCTROCAR | 126FAILS STD | Atlanta District Office (ATL-DO) |
| 8/15/2013 | 74DRCTROCAR | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 8/15/2013 | 74DRCTROCAR | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 6/20/2012 | 78KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES) | New Orleans District Office (NOL-DO) | |
| 6/20/2012 | 78KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES) | New Orleans District Office (NOL-DO) | |
| 6/7/2010 | 79KDDKIT, SURGICAL INSTRUMENT, DISPOSABLE | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Cardinal Health (Kenmex Medical Specialties)'s FDA import refusal history?
Cardinal Health (Kenmex Medical Specialties) (FEI: 3002806934) has 27 FDA import refusal record(s) in our database, spanning from 6/7/2010 to 3/7/2019.
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. Cardinal Health (Kenmex Medical Specialties)'s FEI number is 3002806934.
What types of violations has Cardinal Health (Kenmex Medical Specialties) received?
Cardinal Health (Kenmex Medical Specialties) has been cited for 6 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 Cardinal Health (Kenmex Medical Specialties) come from?
All FDA import refusal data for Cardinal Health (Kenmex Medical Specialties) 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.