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Sharon Bio-Medicine Ltd

⚠️ Moderate Risk

FEI: 3004455093 • Raigad District, Maharashtra • INDIA

FEI

FEI Number

3004455093

📍

Location

Raigad District, Maharashtra

🇮🇳

Country

INDIA
🏢

Address

Plot No. L-6, Midc - Taloja, , Raigad District, Maharashtra, India

Moderate Risk

FDA Import Risk Assessment

38.8
LowModerateHighCritical

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

Statistics

5
Total Refusals
1
Unique Violations
1/20/2022
Latest Refusal
1/20/2022
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
28.8×30%
Recency
6.0×20%
Frequency
50.0×10%
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

22805×

DIRSEXMPT

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.

Refusal History

DateProductViolationsDivision
1/20/2022
61WAS47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
2280DIRSEXMPT
Division of Northeast Imports (DNEI)
1/20/2022
61WAS47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
2280DIRSEXMPT
Division of Northeast Imports (DNEI)
1/20/2022
61WAS47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
2280DIRSEXMPT
Division of Northeast Imports (DNEI)
1/20/2022
61WAS47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
2280DIRSEXMPT
Division of Northeast Imports (DNEI)
1/20/2022
61WAS47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
2280DIRSEXMPT
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Sharon Bio-Medicine Ltd's FDA import refusal history?

Sharon Bio-Medicine Ltd (FEI: 3004455093) has 5 FDA import refusal record(s) in our database, spanning from 1/20/2022 to 1/20/2022.

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. Sharon Bio-Medicine Ltd's FEI number is 3004455093.

What types of violations has Sharon Bio-Medicine Ltd received?

Sharon Bio-Medicine 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 Sharon Bio-Medicine Ltd come from?

All FDA import refusal data for Sharon Bio-Medicine 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.