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UMANG KUMAR

⚠️ Moderate Risk

FEI: 3017305503 • Pune • INDIA

FEI

FEI Number

3017305503

📍

Location

Pune

🇮🇳

Country

INDIA
🏢

Address

Flat No-A404 Jhulelal Tower, , Pune, , India

Moderate Risk

FDA Import Risk Assessment

47.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
10/5/2020
Latest Refusal
10/5/2020
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

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
10/5/2020
62LCA29HYDROXYCHLOROQUINE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL)
75UNAPPROVED
Division of Southeast Imports (DSEI)
10/5/2020
66VAY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Southeast Imports (DSEI)
10/5/2020
61TDA31DOMPERIDONE
75UNAPPROVED
Division of Southeast Imports (DSEI)
10/5/2020
61XCA51LEVOCETIRIZINE DIHYDROCHLORIDE
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is UMANG KUMAR's FDA import refusal history?

UMANG KUMAR (FEI: 3017305503) has 4 FDA import refusal record(s) in our database, spanning from 10/5/2020 to 10/5/2020.

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. UMANG KUMAR's FEI number is 3017305503.

What types of violations has UMANG KUMAR received?

UMANG KUMAR 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 UMANG KUMAR come from?

All FDA import refusal data for UMANG KUMAR 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.