ImportRefusal LogoImportRefusal

Lalan Gloves (Pvt) Ltd.

⚠️ Moderate Risk

FEI: 3003514352 • Biyagama Gampaha • SRI LANKA

FEI

FEI Number

3003514352

📍

Location

Biyagama Gampaha

🇱🇰

Country

SRI LANKA
🏢

Address

Block B, BEPZ, , Biyagama Gampaha, , Sri Lanka

Moderate Risk

FDA Import Risk Assessment

39.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
6/26/2013
Latest Refusal
6/26/2013
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

4774×

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
6/26/2013
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
Los Angeles District Office (LOS-DO)
6/26/2013
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
Los Angeles District Office (LOS-DO)
6/26/2013
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
Los Angeles District Office (LOS-DO)
6/26/2013
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Lalan Gloves (Pvt) Ltd.'s FDA import refusal history?

Lalan Gloves (Pvt) Ltd. (FEI: 3003514352) has 4 FDA import refusal record(s) in our database, spanning from 6/26/2013 to 6/26/2013.

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. Lalan Gloves (Pvt) Ltd.'s FEI number is 3003514352.

What types of violations has Lalan Gloves (Pvt) Ltd. received?

Lalan Gloves (Pvt) Ltd. 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 Lalan Gloves (Pvt) Ltd. come from?

All FDA import refusal data for Lalan Gloves (Pvt) Ltd. 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.