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HINDUSTAN BASIC DRUGS

⚠️ Moderate Risk

FEI: 3003753514 • Mumbai, Maharashtra • INDIA

FEI

FEI Number

3003753514

📍

Location

Mumbai, Maharashtra

🇮🇳

Country

INDIA
🏢

Address

F-28,27,26.13 & 14 NANDDHAM INDUSTRIAL ESTATE, MAROL ANDHERI EAST, Mumbai, Maharashtra, India

Moderate Risk

FDA Import Risk Assessment

27.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
4/9/2010
Latest Refusal
3/4/2010
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

1182×

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
4/9/2010
64NAR04FERROUS FUMARATE (HEMATINIC)
118NOT LISTED
Detroit District Office (DET-DO)
3/4/2010
64NAS04FERROUS FUMARATE (HEMATINIC)
118NOT LISTED
Detroit District Office (DET-DO)

Frequently Asked Questions

What is HINDUSTAN BASIC DRUGS's FDA import refusal history?

HINDUSTAN BASIC DRUGS (FEI: 3003753514) has 2 FDA import refusal record(s) in our database, spanning from 3/4/2010 to 4/9/2010.

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. HINDUSTAN BASIC DRUGS's FEI number is 3003753514.

What types of violations has HINDUSTAN BASIC DRUGS received?

HINDUSTAN BASIC DRUGS 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 HINDUSTAN BASIC DRUGS come from?

All FDA import refusal data for HINDUSTAN BASIC DRUGS 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.