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Suretex Prophylactics (India) Limited

⚠️ Moderate Risk

FEI: 3001687671 • Jigani, Karnataka • INDIA

FEI

FEI Number

3001687671

📍

Location

Jigani, Karnataka

🇮🇳

Country

INDIA
🏢

Address

74 - 91 Anekal Taluk, Kiadb, Jigani, Karnataka, India

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
2/25/2003
Latest Refusal
2/25/2003
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
2/25/2003
85HISCONDOM
477HOLES
Atlanta District Office (ATL-DO)

Frequently Asked Questions

What is Suretex Prophylactics (India) Limited's FDA import refusal history?

Suretex Prophylactics (India) Limited (FEI: 3001687671) has 1 FDA import refusal record(s) in our database, spanning from 2/25/2003 to 2/25/2003.

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. Suretex Prophylactics (India) Limited's FEI number is 3001687671.

What types of violations has Suretex Prophylactics (India) Limited received?

Suretex Prophylactics (India) Limited 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 Suretex Prophylactics (India) Limited come from?

All FDA import refusal data for Suretex Prophylactics (India) Limited 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.