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Prime Polymers

⚠️ Moderate Risk

FEI: 3003615370 • Avissawella, Colombo • SRI LANKA

FEI

FEI Number

3003615370

📍

Location

Avissawella, Colombo

🇱🇰

Country

SRI LANKA
🏢

Address

D-17, Seethawaka Industrial Park, , Avissawella, Colombo, Sri Lanka

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
1/16/2003
Latest Refusal
1/16/2003
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

4771×

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
1/16/2003
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
New England District Office (NWE-DO)

Frequently Asked Questions

What is Prime Polymers's FDA import refusal history?

Prime Polymers (FEI: 3003615370) has 1 FDA import refusal record(s) in our database, spanning from 1/16/2003 to 1/16/2003.

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. Prime Polymers's FEI number is 3003615370.

What types of violations has Prime Polymers received?

Prime Polymers 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 Prime Polymers come from?

All FDA import refusal data for Prime Polymers 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.