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Shilpa Pharma Lifesciences Limited

⚠️ Moderate Risk

FEI: 3007197995 • Raichur, Karnataka • INDIA

FEI

FEI Number

3007197995

📍

Location

Raichur, Karnataka

🇮🇳

Country

INDIA
🏢

Address

Unit 2, Plot No.33,33A & 40 to 47, Raichur Industrial Growth Centre, Chicksugur, Raichur, Karnataka, India

Moderate Risk

FDA Import Risk Assessment

48.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
2/9/2023
Latest Refusal
11/29/2018
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
26.5×20%
Frequency
7.1×10%
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

753×

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
2/9/2023
60YIY99INHIBITOR (GROWTH FACTOR) N.E.C.
75UNAPPROVED
Division of West Coast Imports (DWCI)
2/9/2023
60YIY99INHIBITOR (GROWTH FACTOR) N.E.C.
75UNAPPROVED
Division of West Coast Imports (DWCI)
11/29/2018
62ICZ99ANTI-NEOPLASTIC N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Shilpa Pharma Lifesciences Limited's FDA import refusal history?

Shilpa Pharma Lifesciences Limited (FEI: 3007197995) has 3 FDA import refusal record(s) in our database, spanning from 11/29/2018 to 2/9/2023.

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. Shilpa Pharma Lifesciences Limited's FEI number is 3007197995.

What types of violations has Shilpa Pharma Lifesciences Limited received?

Shilpa Pharma Lifesciences Limited 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 Shilpa Pharma Lifesciences Limited come from?

All FDA import refusal data for Shilpa Pharma Lifesciences Limited 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.