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Dr Hemlata Murthy

⚠️ Moderate Risk

FEI: 3004410452 • Pune, Maharashtra • INDIA

FEI

FEI Number

3004410452

📍

Location

Pune, Maharashtra

🇮🇳

Country

INDIA
🏢

Address

35 Vishnu Smruti, , Pune, Maharashtra, India

Moderate Risk

FDA Import Risk Assessment

39.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
2
Unique Violations
2/27/2004
Latest Refusal
2/27/2004
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

1184×

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).

754×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
2/27/2004
63BDQ25FLUTICASONE PROPIONATE (BRONCHODILATOR)
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
2/27/2004
63BDL22TERBUTALINE SULFATE (BRONCHODILATOR)
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
2/27/2004
66SCB27NIFEDIPINE (VASODILATOR)
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
2/27/2004
56BCE03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Dr Hemlata Murthy's FDA import refusal history?

Dr Hemlata Murthy (FEI: 3004410452) has 4 FDA import refusal record(s) in our database, spanning from 2/27/2004 to 2/27/2004.

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. Dr Hemlata Murthy's FEI number is 3004410452.

What types of violations has Dr Hemlata Murthy received?

Dr Hemlata Murthy 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 Dr Hemlata Murthy come from?

All FDA import refusal data for Dr Hemlata Murthy 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.