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Belamie Fine Chemicals Pvt Ltd

✅ Low Risk

FEI: 3007036365 • Mumbai, Maharashtra • INDIA

FEI

FEI Number

3007036365

📍

Location

Mumbai, Maharashtra

🇮🇳

Country

INDIA
🏢

Address

2nd Floor, 199 Princess St 29, Mumbai, Maharashtra, India

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
12/18/2008
Latest Refusal
12/18/2008
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

1181×

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
12/18/2008
62FDR14GENTIAN VIOLET (ANTI-INFECTIVE, TOPICAL)
118NOT LISTED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Belamie Fine Chemicals Pvt Ltd's FDA import refusal history?

Belamie Fine Chemicals Pvt Ltd (FEI: 3007036365) has 1 FDA import refusal record(s) in our database, spanning from 12/18/2008 to 12/18/2008.

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. Belamie Fine Chemicals Pvt Ltd's FEI number is 3007036365.

What types of violations has Belamie Fine Chemicals Pvt Ltd received?

Belamie Fine Chemicals 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 Belamie Fine Chemicals Pvt Ltd come from?

All FDA import refusal data for Belamie Fine Chemicals 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.