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SKANRAY TECHNOLOGIES PVT LTD

⚠️ Moderate Risk

FEI: 3009001657 • Mysore, Karnataka • INDIA

FEI

FEI Number

3009001657

📍

Location

Mysore, Karnataka

🇮🇳

Country

INDIA
🏢

Address

15 - 17 Plot#, , Mysore, Karnataka, India

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
3/4/2011
Latest Refusal
3/4/2011
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

4761×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

Refusal History

DateProductViolationsDivision
3/4/2011
76EAPUNIT, X-RAY, INTRAORAL
476NO REGISTR
New York District Office (NYK-DO)

Frequently Asked Questions

What is SKANRAY TECHNOLOGIES PVT LTD's FDA import refusal history?

SKANRAY TECHNOLOGIES PVT LTD (FEI: 3009001657) has 1 FDA import refusal record(s) in our database, spanning from 3/4/2011 to 3/4/2011.

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. SKANRAY TECHNOLOGIES PVT LTD's FEI number is 3009001657.

What types of violations has SKANRAY TECHNOLOGIES PVT LTD received?

SKANRAY TECHNOLOGIES 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 SKANRAY TECHNOLOGIES PVT LTD come from?

All FDA import refusal data for SKANRAY TECHNOLOGIES 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.