Cardinal Health 222 (Thailand) Limited
⚠️ Moderate Risk
FEI: 3004048089 • Pluak Daeng, Rayong • THAILAND
FEI Number
3004048089
Location
Pluak Daeng, Rayong
Country
THAILANDAddress
7, 111 Moo 4 highway, Pluak Daeng, Rayong, Thailand
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
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).
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/5/2015 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 118NOT LISTED | New England District Office (NWE-DO) |
| 2/5/2015 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 118NOT LISTED | New England District Office (NWE-DO) |
| 2/5/2015 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 118NOT LISTED | New England District Office (NWE-DO) |
| 2/5/2015 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 118NOT LISTED | New England District Office (NWE-DO) |
| 1/19/2010 | 79KGOSURGEON'S GLOVES | 126FAILS STD | Los Angeles District Office (LOS-DO) |
| 5/1/2009 | 79KGOSURGEON'S GLOVES | 477HOLES | Los Angeles District Office (LOS-DO) |
| 4/29/2009 | 79KGOSURGEON'S GLOVES | 477HOLES | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Cardinal Health 222 (Thailand) Limited's FDA import refusal history?
Cardinal Health 222 (Thailand) Limited (FEI: 3004048089) has 7 FDA import refusal record(s) in our database, spanning from 4/29/2009 to 2/5/2015.
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. Cardinal Health 222 (Thailand) Limited's FEI number is 3004048089.
What types of violations has Cardinal Health 222 (Thailand) Limited received?
Cardinal Health 222 (Thailand) Limited 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 Cardinal Health 222 (Thailand) Limited come from?
All FDA import refusal data for Cardinal Health 222 (Thailand) Limited 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.