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Kailash

⚠️ Moderate Risk

FEI: 3004439991 • New Kelhi • INDIA

FEI

FEI Number

3004439991

📍

Location

New Kelhi

🇮🇳

Country

INDIA
🏢

Address

26/166 Lgf Vikram Vihar, , New Kelhi, , 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
2
Unique Violations
4/20/2004
Latest Refusal
4/20/2004
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

1151×

DR QUALITY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

Refusal History

DateProductViolationsDivision
4/20/2004
54ACA99VITAMIN, N.E.C.
115DR QUALITY
16DIRECTIONS
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Kailash's FDA import refusal history?

Kailash (FEI: 3004439991) has 1 FDA import refusal record(s) in our database, spanning from 4/20/2004 to 4/20/2004.

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. Kailash's FEI number is 3004439991.

What types of violations has Kailash received?

Kailash has been cited for 2 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 Kailash come from?

All FDA import refusal data for Kailash 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.