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Mr Madan Paul

⚠️ High Risk

FEI: 3009241718 • Nagar • INDIA

FEI

FEI Number

3009241718

📍

Location

Nagar

🇮🇳

Country

INDIA
🏢

Address

St No 1 Mohar Singh, , Nagar, , India

High Risk

FDA Import Risk Assessment

53.0
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

7
Total Refusals
1
Unique Violations
1/6/2012
Latest Refusal
1/6/2012
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
33.5×30%
Recency
0.0×20%
Frequency
70.0×10%
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

757×

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
1/6/2012
61TCA17PROMETHAZINE HCL (ANTI-EMETIC/NAUSEANT)
75UNAPPROVED
New York District Office (NYK-DO)
1/6/2012
61TCA26ONDANSETRON (ANTI-EMETIC/NAUSEANT)
75UNAPPROVED
New York District Office (NYK-DO)
1/6/2012
62KCA99ANTI-PERISTALTIC N.E.C.
75UNAPPROVED
New York District Office (NYK-DO)
1/6/2012
66MCA09BUSPIRONE HCL (TRANQUILIZER)
75UNAPPROVED
New York District Office (NYK-DO)
1/6/2012
61NCA05BUPROPION HCL (ANTI-DEPRESSANT)
75UNAPPROVED
New York District Office (NYK-DO)
1/6/2012
60LDA01ACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
New York District Office (NYK-DO)
1/6/2012
60LCA14CARBAMAZEPINE (ANALGESIC)
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Mr Madan Paul's FDA import refusal history?

Mr Madan Paul (FEI: 3009241718) has 7 FDA import refusal record(s) in our database, spanning from 1/6/2012 to 1/6/2012.

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. Mr Madan Paul's FEI number is 3009241718.

What types of violations has Mr Madan Paul received?

Mr Madan Paul 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 Mr Madan Paul come from?

All FDA import refusal data for Mr Madan Paul 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.