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SUN PHARMA INDUSTIRIES LTD

⚠️ Moderate Risk

FEI: 3016877844 • New Delhi, Delhi • INDIA

FEI

FEI Number

3016877844

📍

Location

New Delhi, Delhi

🇮🇳

Country

INDIA
🏢

Address

Plot No A - 41, Sez Unit - 1, New Delhi, Delhi, India

Moderate Risk

FDA Import Risk Assessment

49.3
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
2/27/2023
Latest Refusal
7/20/2020
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
27.5×20%
Frequency
11.5×10%
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
2/27/2023
66YIS99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
2/27/2023
63BAY99BRONCHODILATOR N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
7/20/2020
61TDY31DOMPERIDONE
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SUN PHARMA INDUSTIRIES LTD's FDA import refusal history?

SUN PHARMA INDUSTIRIES LTD (FEI: 3016877844) has 3 FDA import refusal record(s) in our database, spanning from 7/20/2020 to 2/27/2023.

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. SUN PHARMA INDUSTIRIES LTD's FEI number is 3016877844.

What types of violations has SUN PHARMA INDUSTIRIES LTD received?

SUN PHARMA INDUSTIRIES 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 SUN PHARMA INDUSTIRIES LTD come from?

All FDA import refusal data for SUN PHARMA INDUSTIRIES 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.