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Solumiks Herbaceuticals Ltd

⚠️ Moderate Risk

FEI: 3006937113 • Mumbai, Maharashtra • INDIA

FEI

FEI Number

3006937113

📍

Location

Mumbai, Maharashtra

🇮🇳

Country

INDIA
🏢

Address

135 Desai Road, , Mumbai, Maharashtra, India

Moderate Risk

FDA Import Risk Assessment

34.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
6/24/2008
Latest Refusal
6/24/2008
Earliest Refusal

Score Breakdown

Violation Severity
75.0×40%
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.

3301×

UNSAFE COL

The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).

Refusal History

DateProductViolationsDivision
6/24/2008
66VCP99MISCELLANEOUS PATENT MEDICINES, ETC.
115DR QUALITY
330UNSAFE COL
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Solumiks Herbaceuticals Ltd's FDA import refusal history?

Solumiks Herbaceuticals Ltd (FEI: 3006937113) has 1 FDA import refusal record(s) in our database, spanning from 6/24/2008 to 6/24/2008.

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. Solumiks Herbaceuticals Ltd's FEI number is 3006937113.

What types of violations has Solumiks Herbaceuticals Ltd received?

Solumiks Herbaceuticals Ltd 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 Solumiks Herbaceuticals Ltd come from?

All FDA import refusal data for Solumiks Herbaceuticals 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.