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KHANDELWAL LABORATORPES PVT LTD

⚠️ High Risk

FEI: 3014685229 • Nagar • INDIA

FEI

FEI Number

3014685229

📍

Location

Nagar

🇮🇳

Country

INDIA
🏢

Address

Plot No 20, Sector 60, , Nagar, , India

High Risk

FDA Import Risk Assessment

50.4
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
7/16/2025
Latest Refusal
7/16/2025
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
90.2×20%
Frequency
10.0×10%
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

821×

RX LEGEND

The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).

Refusal History

DateProductViolationsDivision
7/16/2025
62GDA18DICLOFENAC SODIUM (ANTI-INFLAMMATORY)
82RX LEGEND
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is KHANDELWAL LABORATORPES PVT LTD's FDA import refusal history?

KHANDELWAL LABORATORPES PVT LTD (FEI: 3014685229) has 1 FDA import refusal record(s) in our database, spanning from 7/16/2025 to 7/16/2025.

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. KHANDELWAL LABORATORPES PVT LTD's FEI number is 3014685229.

What types of violations has KHANDELWAL LABORATORPES PVT LTD received?

KHANDELWAL LABORATORPES PVT LTD 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 KHANDELWAL LABORATORPES PVT LTD come from?

All FDA import refusal data for KHANDELWAL LABORATORPES PVT LTD 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.