Pt. Maja Agung Latexindo

⚠️ Moderate Risk

FEI: 3000239897 • Sumatra • INDONESIA

FEI

FEI Number

3000239897

📍

Location

Sumatra

🇮🇩

Country

INDONESIA

🏢

Address

Jl Utama No. 98 Puji Mulio, Sunggal Deli Serdang, Sumatra, , Indonesia

Moderate Risk

FDA Import Risk Assessment

40.3

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

2/20/2014

Latest Refusal

10/25/2002

Earliest Refusal

Score Breakdown

Violation Severity

72.5×40%

Refusal Volume

35.3×30%

Recency

0.0×20%

Frequency

7.1×10%

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

4777×

HOLES

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

1861×

INSANITARY

The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.

Refusal History

Date	Product	Violations	Division
2/20/2014	80LYYGLOVE, PATIENT EXAMINATION, LATEX	477HOLES	Los Angeles District Office (LOS-DO)
2/20/2014	80LYYGLOVE, PATIENT EXAMINATION, LATEX	477HOLES	Los Angeles District Office (LOS-DO)
2/20/2014	80LYYGLOVE, PATIENT EXAMINATION, LATEX	477HOLES	Los Angeles District Office (LOS-DO)
3/9/2011	80LZAGLOVE, PATIENT EXAMINATION, POLY	186INSANITARY	Los Angeles District Office (LOS-DO)
1/24/2011	79KGOSURGEON'S GLOVES	477HOLES	Florida District Office (FLA-DO)
3/28/2008	80LYYGLOVE, PATIENT EXAMINATION, LATEX	477HOLES	Seattle District Office (SEA-DO)
2/15/2008	80LYYGLOVE, PATIENT EXAMINATION, LATEX	477HOLES	Philadelphia District Office (PHI-DO)
10/25/2002	80LYYGLOVE, PATIENT EXAMINATION, LATEX	477HOLES	New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Pt. Maja Agung Latexindo's FDA import refusal history?

Pt. Maja Agung Latexindo (FEI: 3000239897) has 8 FDA import refusal record(s) in our database, spanning from 10/25/2002 to 2/20/2014.

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. Pt. Maja Agung Latexindo's FEI number is 3000239897.

What types of violations has Pt. Maja Agung Latexindo received?

Pt. Maja Agung Latexindo 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 Pt. Maja Agung Latexindo come from?

All FDA import refusal data for Pt. Maja Agung Latexindo 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.