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SAMARTH LIFE SCIENCES PVT LTD

⚠️ Moderate Risk

FEI: 3014938732 • Mumbai, Maharashtra • INDIA

FEI

FEI Number

3014938732

📍

Location

Mumbai, Maharashtra

🇮🇳

Country

INDIA
🏢

Address

174101 Himachal Pradeshsolan Nalagarh Nangal Upa, , Mumbai, Maharashtra, India

Moderate Risk

FDA Import Risk Assessment

45.2
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
12/13/2022
Latest Refusal
12/13/2022
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
24.4×20%
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

751×

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
12/13/2022
56BCE51PENICILLAMINE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

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

SAMARTH LIFE SCIENCES PVT LTD (FEI: 3014938732) has 1 FDA import refusal record(s) in our database, spanning from 12/13/2022 to 12/13/2022.

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. SAMARTH LIFE SCIENCES PVT LTD's FEI number is 3014938732.

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

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 SAMARTH LIFE SCIENCES PVT LTD come from?

All FDA import refusal data for 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.