Adventa Health Sdn Bhd

⚠️ Moderate Risk

FEI: 3005689707 • Kota Bharu, Kelantan • MALAYSIA

FEI

FEI Number

3005689707

📍

Location

Kota Bharu, Kelantan

🇲🇾

Country

MALAYSIA

🏢

Address

1 Jalan Pengkalan Chepa, , Kota Bharu, Kelantan, Malaysia

Moderate Risk

FDA Import Risk Assessment

37.9

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

2/7/2012

Latest Refusal

10/1/2007

Earliest Refusal

Score Breakdown

Violation Severity

65.6×40%

Refusal Volume

33.5×30%

Recency

0.0×20%

Frequency

16.1×10%

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

Violation Summary

4774×

HOLES

The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.

5083×

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.

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).

Refusal History

Date	Product	Violations	Division
2/7/2012	80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY	508NO 510(K)	Detroit District Office (DET-DO)
2/7/2012	90IWPGLOVE, PROTECTIVE, RADIOGRAPHIC	118NOT LISTED 508NO 510(K)	Detroit District Office (DET-DO)
10/25/2011	79KGOSURGEON'S GLOVES	477HOLES	Los Angeles District Office (LOS-DO)
10/25/2011	79KGOSURGEON'S GLOVES	477HOLES	Los Angeles District Office (LOS-DO)
10/25/2011	79KGOSURGEON'S GLOVES	477HOLES	Los Angeles District Office (LOS-DO)
10/25/2011	79KGOSURGEON'S GLOVES	477HOLES	Los Angeles District Office (LOS-DO)
10/1/2007	79KGOSURGEON'S GLOVES	118NOT LISTED 508NO 510(K)	New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Adventa Health Sdn Bhd's FDA import refusal history?

Adventa Health Sdn Bhd (FEI: 3005689707) has 7 FDA import refusal record(s) in our database, spanning from 10/1/2007 to 2/7/2012.

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. Adventa Health Sdn Bhd's FEI number is 3005689707.

What types of violations has Adventa Health Sdn Bhd received?

Adventa Health Sdn Bhd 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 Adventa Health Sdn Bhd come from?

All FDA import refusal data for Adventa Health Sdn Bhd 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.