Brightway Holdings SDN BHD

⚠️ Moderate Risk

FEI: 1000153304 • Klang, Selangor • MALAYSIA

FEI

FEI Number

1000153304

📍

Location

Klang, Selangor

🇲🇾

Country

MALAYSIA

🏢

Address

Lot 1559, 1 Jalan Istimewa, BATU BELAH, Klang, Selangor, Malaysia

Moderate Risk

FDA Import Risk Assessment

43.3

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

2/5/2013

Latest Refusal

5/7/2007

Earliest Refusal

Score Breakdown

Violation Severity

67.1×40%

Refusal Volume

45.6×30%

Recency

0.0×20%

Frequency

27.8×10%

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

47716×

HOLES

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

3331×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

Refusal History

Date	Product	Violations	Division
2/5/2013	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	New Orleans District Office (NOL-DO)
11/27/2012	80LYYGLOVE, PATIENT EXAMINATION, LATEX	477HOLES	Chicago District Office (CHI-DO)
10/10/2012	80FMCGLOVE, PATIENT EXAMINATION	477HOLES	Division of Southeast Imports (DSEI)
10/10/2012	80LYYGLOVE, PATIENT EXAMINATION, LATEX	477HOLES	Division of Southeast Imports (DSEI)
9/10/2012	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	New Orleans District Office (NOL-DO)
9/10/2012	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	New Orleans District Office (NOL-DO)
9/5/2012	80LZAGLOVE, PATIENT EXAMINATION, POLY	333LACKS FIRM 477HOLES	New Orleans District Office (NOL-DO)
9/12/2011	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	New York District Office (NYK-DO)
9/12/2011	80FMCGLOVE, PATIENT EXAMINATION	477HOLES	New York District Office (NYK-DO)
9/12/2011	80FMCGLOVE, PATIENT EXAMINATION	477HOLES	New York District Office (NYK-DO)
9/12/2011	80FMCGLOVE, PATIENT EXAMINATION	477HOLES	New York District Office (NYK-DO)
9/12/2011	80FMCGLOVE, PATIENT EXAMINATION	477HOLES	New York District Office (NYK-DO)
9/12/2011	80FMCGLOVE, PATIENT EXAMINATION	477HOLES	New York District Office (NYK-DO)
7/1/2009	79KGOSURGEON'S GLOVES	477HOLES	Los Angeles District Office (LOS-DO)
5/7/2007	80LYYGLOVE, PATIENT EXAMINATION, LATEX	477HOLES	Atlanta District Office (ATL-DO)
5/7/2007	80LYYGLOVE, PATIENT EXAMINATION, LATEX	477HOLES	Atlanta District Office (ATL-DO)

Frequently Asked Questions

What is Brightway Holdings SDN BHD's FDA import refusal history?

Brightway Holdings SDN BHD (FEI: 1000153304) has 16 FDA import refusal record(s) in our database, spanning from 5/7/2007 to 2/5/2013.

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. Brightway Holdings SDN BHD's FEI number is 1000153304.

What types of violations has Brightway Holdings SDN BHD received?

Brightway Holdings SDN BHD has been cited for 2 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 Brightway Holdings SDN BHD come from?

All FDA import refusal data for Brightway Holdings 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.