Perusahaan Getah Asas SDN BHD

⚠️ Moderate Risk

FEI: 1000184859 • Selangor, Selangor Darul Ehsan • MALAYSIA

FEI

FEI Number

1000184859

📍

Location

Selangor, Selangor Darul Ehsan

🇲🇾

Country

MALAYSIA

🏢

Address

Lot 754, Jalan Haji Sirat, , Selangor, Selangor Darul Ehsan, Malaysia

Moderate Risk

FDA Import Risk Assessment

49.4

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

8/27/2009

Latest Refusal

7/12/2006

Earliest Refusal

Score Breakdown

Violation Severity

72.1×40%

Refusal Volume

48.2×30%

Recency

0.0×20%

Frequency

60.7×10%

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

47715×

HOLES

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

1264×

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
8/27/2009	80LYYGLOVE, PATIENT EXAMINATION, LATEX	477HOLES	New York District Office (NYK-DO)
8/27/2009	80LYYGLOVE, PATIENT EXAMINATION, LATEX	477HOLES	New York District Office (NYK-DO)
8/27/2009	80LYYGLOVE, PATIENT EXAMINATION, LATEX	477HOLES	New York District Office (NYK-DO)
11/13/2006	80LYYGLOVE, PATIENT EXAMINATION, LATEX	477HOLES	Los Angeles District Office (LOS-DO)
11/13/2006	80LYYGLOVE, PATIENT EXAMINATION, LATEX	477HOLES	Los Angeles District Office (LOS-DO)
10/19/2006	80FMCGLOVE, PATIENT EXAMINATION	126FAILS STD	Southwest Import District Office (SWI-DO)
10/19/2006	80FMCGLOVE, PATIENT EXAMINATION	126FAILS STD	Southwest Import District Office (SWI-DO)
10/19/2006	80FMCGLOVE, PATIENT EXAMINATION	126FAILS STD	Southwest Import District Office (SWI-DO)
10/19/2006	80FMCGLOVE, PATIENT EXAMINATION	126FAILS STD	Southwest Import District Office (SWI-DO)
8/21/2006	80FMCGLOVE, PATIENT EXAMINATION	477HOLES	Southwest Import District Office (SWI-DO)
8/21/2006	80FMCGLOVE, PATIENT EXAMINATION	477HOLES	Southwest Import District Office (SWI-DO)
8/21/2006	80FMCGLOVE, PATIENT EXAMINATION	477HOLES	Southwest Import District Office (SWI-DO)
8/21/2006	80FMCGLOVE, PATIENT EXAMINATION	477HOLES	Southwest Import District Office (SWI-DO)
7/17/2006	80LYYGLOVE, PATIENT EXAMINATION, LATEX	477HOLES	Cincinnati District Office (CIN-DO)
7/14/2006	80LYYGLOVE, PATIENT EXAMINATION, LATEX	477HOLES	Cincinnati District Office (CIN-DO)
7/14/2006	80LYYGLOVE, PATIENT EXAMINATION, LATEX	477HOLES	Cincinnati District Office (CIN-DO)
7/14/2006	80LYYGLOVE, PATIENT EXAMINATION, LATEX	477HOLES	Cincinnati District Office (CIN-DO)
7/14/2006	80LYYGLOVE, PATIENT EXAMINATION, LATEX	477HOLES	Cincinnati District Office (CIN-DO)
7/12/2006	80LYYGLOVE, PATIENT EXAMINATION, LATEX	477HOLES	Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Perusahaan Getah Asas SDN BHD's FDA import refusal history?

Perusahaan Getah Asas SDN BHD (FEI: 1000184859) has 19 FDA import refusal record(s) in our database, spanning from 7/12/2006 to 8/27/2009.

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. Perusahaan Getah Asas SDN BHD's FEI number is 1000184859.

What types of violations has Perusahaan Getah Asas SDN BHD received?

Perusahaan Getah Asas 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 Perusahaan Getah Asas SDN BHD come from?

All FDA import refusal data for Perusahaan Getah Asas 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.