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Pt Abbvergummi Medical

⚠️ Moderate Risk

FEI: 3003488962 • Sidvaajo • INDONESIA

FEI

FEI Number

3003488962

📍

Location

Sidvaajo

🇮🇩

Country

INDONESIA
🏢

Address

Komplek Balur Jaltim, , Sidvaajo, , Indonesia

Moderate Risk

FDA Import Risk Assessment

35.8
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
7/19/2007
Latest Refusal
11/30/2004
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
11.4×10%
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

© ImportRefusal.com Original Analysis

Violation Summary

4773×

HOLES

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

Refusal History

DateProductViolationsDivision
7/19/2007
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
Los Angeles District Office (LOS-DO)
11/30/2004
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
Los Angeles District Office (LOS-DO)
11/30/2004
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Pt Abbvergummi Medical's FDA import refusal history?

Pt Abbvergummi Medical (FEI: 3003488962) has 3 FDA import refusal record(s) in our database, spanning from 11/30/2004 to 7/19/2007.

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 Abbvergummi Medical's FEI number is 3003488962.

What types of violations has Pt Abbvergummi Medical received?

Pt Abbvergummi Medical has been cited for 1 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 Abbvergummi Medical come from?

All FDA import refusal data for Pt Abbvergummi Medical 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.