Cardinal Health Malaysia 211 Sdn. Bhn.
⚠️ Moderate Risk
FEI: 3000698549 • Bayan Lepas, Pulau Pinang • MALAYSIA
FEI Number
3000698549
Location
Bayan Lepas, Pulau Pinang
Country
MALAYSIAAddress
Zone Phase Iv, Mk Lintang, Lintang Bayan Lepas 3, Bayan Lepas, Pulau Pinang, Malaysia
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
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
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).
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).
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
Frequently Asked Questions
What is Cardinal Health Malaysia 211 Sdn. Bhn.'s FDA import refusal history?
Cardinal Health Malaysia 211 Sdn. Bhn. (FEI: 3000698549) has 3 FDA import refusal record(s) in our database, spanning from 11/20/2002 to 10/27/2003.
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 Malaysia 211 Sdn. Bhn.'s FEI number is 3000698549.
What types of violations has Cardinal Health Malaysia 211 Sdn. Bhn. received?
Cardinal Health Malaysia 211 Sdn. Bhn. has been cited for 4 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 Malaysia 211 Sdn. Bhn. come from?
All FDA import refusal data for Cardinal Health Malaysia 211 Sdn. Bhn. 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.