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Pradeep Shrestha

⚠️ Moderate Risk

FEI: 3005187236 • Lalitpur, Lalitpur • NEPAL

FEI

FEI Number

3005187236

📍

Location

Lalitpur, Lalitpur

🇳🇵

Country

NEPAL
🏢

Address

Satdobato, , Lalitpur, Lalitpur, Nepal

Moderate Risk

FDA Import Risk Assessment

45.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
7/8/2005
Latest Refusal
7/8/2005
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

753×

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
7/8/2005
62LCO09TINIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL)
75UNAPPROVED
Cincinnati District Office (CIN-DO)
7/8/2005
61FCK54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC)
75UNAPPROVED
Cincinnati District Office (CIN-DO)
7/8/2005
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Pradeep Shrestha's FDA import refusal history?

Pradeep Shrestha (FEI: 3005187236) has 3 FDA import refusal record(s) in our database, spanning from 7/8/2005 to 7/8/2005.

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. Pradeep Shrestha's FEI number is 3005187236.

What types of violations has Pradeep Shrestha received?

Pradeep Shrestha 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 Pradeep Shrestha come from?

All FDA import refusal data for Pradeep Shrestha 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.