ImportRefusal LogoImportRefusal

SL SAMARTH LIFE SCIENCES PVT LTD

⚠️ Moderate Risk

FEI: 3041492322 • Pradesh • INDIA

FEI

FEI Number

3041492322

📍

Location

Pradesh

🇮🇳

Country

INDIA
🏢

Address

Plot 86/1 Davni Ind, , Pradesh, , India

Moderate Risk

FDA Import Risk Assessment

44.1
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
12/17/2025
Latest Refusal
12/17/2025
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
98.6×20%
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

1181×

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).

Refusal History

DateProductViolationsDivision
12/17/2025
63NCA09PYRIDOSTIGMINE BROMIDE (CHOLINERGIC)
118NOT LISTED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SL SAMARTH LIFE SCIENCES PVT LTD's FDA import refusal history?

SL SAMARTH LIFE SCIENCES PVT LTD (FEI: 3041492322) has 1 FDA import refusal record(s) in our database, spanning from 12/17/2025 to 12/17/2025.

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. SL SAMARTH LIFE SCIENCES PVT LTD's FEI number is 3041492322.

What types of violations has SL SAMARTH LIFE SCIENCES PVT LTD received?

SL SAMARTH LIFE SCIENCES 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 SL SAMARTH LIFE SCIENCES PVT LTD come from?

All FDA import refusal data for SL SAMARTH LIFE SCIENCES 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.