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SAI PRIMUS LIFE BIOTECT PVT LTD

⚠️ Moderate Risk

FEI: 3017191558 • Villianur Commune • INDIA

FEI

FEI Number

3017191558

📍

Location

Villianur Commune

🇮🇳

Country

INDIA
🏢

Address

Factory:R.S.No.4/3,Plotno.33,Kurumbapet Industria, , Villianur Commune, , India

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
8/19/2020
Latest Refusal
8/19/2020
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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
8/19/2020
61TBY31DOMPERIDONE
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SAI PRIMUS LIFE BIOTECT PVT LTD's FDA import refusal history?

SAI PRIMUS LIFE BIOTECT PVT LTD (FEI: 3017191558) has 1 FDA import refusal record(s) in our database, spanning from 8/19/2020 to 8/19/2020.

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. SAI PRIMUS LIFE BIOTECT PVT LTD's FEI number is 3017191558.

What types of violations has SAI PRIMUS LIFE BIOTECT PVT LTD received?

SAI PRIMUS LIFE BIOTECT 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 SAI PRIMUS LIFE BIOTECT PVT LTD come from?

All FDA import refusal data for SAI PRIMUS LIFE BIOTECT 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.