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Global Bulk Drugs & Fine Chemicals

⚠️ Moderate Risk

FEI: 3003120118 • Hyderabad • INDIA

FEI

FEI Number

3003120118

📍

Location

Hyderabad

🇮🇳

Country

INDIA
🏢

Address

5-9-30 Road No 4, , Hyderabad, , India

Moderate Risk

FDA Import Risk Assessment

26.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
4/12/2004
Latest Refusal
4/12/2004
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
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

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.

28801×

RXCOMPOUND

the labeling fails to bear, at a minimum, the symbol "Rx only."

Refusal History

DateProductViolationsDivision
4/12/2004
61WCS47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
16DIRECTIONS
2880RXCOMPOUND
Detroit District Office (DET-DO)

Frequently Asked Questions

What is Global Bulk Drugs & Fine Chemicals's FDA import refusal history?

Global Bulk Drugs & Fine Chemicals (FEI: 3003120118) has 1 FDA import refusal record(s) in our database, spanning from 4/12/2004 to 4/12/2004.

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. Global Bulk Drugs & Fine Chemicals's FEI number is 3003120118.

What types of violations has Global Bulk Drugs & Fine Chemicals received?

Global Bulk Drugs & Fine Chemicals 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 Global Bulk Drugs & Fine Chemicals come from?

All FDA import refusal data for Global Bulk Drugs & Fine Chemicals 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.