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Sunehari Svendgaard Laboratories

⚠️ Moderate Risk

FEI: 3002795420 • New Delhi, Delhi • INDIA

FEI

FEI Number

3002795420

📍

Location

New Delhi, Delhi

🇮🇳

Country

INDIA
🏢

Address

B - 1e/23 Mathura Road, , New Delhi, Delhi, India

Moderate Risk

FDA Import Risk Assessment

31.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
6/14/2006
Latest Refusal
6/14/2006
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

1184×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
6/14/2006
63RAY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC)
118NOT LISTED
Los Angeles District Office (LOS-DO)
6/14/2006
63RAY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC)
118NOT LISTED
Los Angeles District Office (LOS-DO)
6/14/2006
63RAY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC)
118NOT LISTED
Los Angeles District Office (LOS-DO)
6/14/2006
63RAY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC)
118NOT LISTED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Sunehari Svendgaard Laboratories's FDA import refusal history?

Sunehari Svendgaard Laboratories (FEI: 3002795420) has 4 FDA import refusal record(s) in our database, spanning from 6/14/2006 to 6/14/2006.

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. Sunehari Svendgaard Laboratories's FEI number is 3002795420.

What types of violations has Sunehari Svendgaard Laboratories received?

Sunehari Svendgaard Laboratories 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 Sunehari Svendgaard Laboratories come from?

All FDA import refusal data for Sunehari Svendgaard Laboratories 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.