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FRANCO INDIAN PHARMA PVT LTD

⚠️ High Risk

FEI: 3017032284 • Ahmedabad, Gujarat • INDIA

FEI

FEI Number

3017032284

📍

Location

Ahmedabad, Gujarat

🇮🇳

Country

INDIA
🏢

Address

C/8 Kb House, Mahamdabad Khokhara Road, Ahmedabad, Gujarat, India

High Risk

FDA Import Risk Assessment

58.2
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

1
Total Refusals
1
Unique Violations
6/30/2025
Latest Refusal
6/30/2025
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
89.1×20%
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
6/30/2025
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is FRANCO INDIAN PHARMA PVT LTD's FDA import refusal history?

FRANCO INDIAN PHARMA PVT LTD (FEI: 3017032284) has 1 FDA import refusal record(s) in our database, spanning from 6/30/2025 to 6/30/2025.

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. FRANCO INDIAN PHARMA PVT LTD's FEI number is 3017032284.

What types of violations has FRANCO INDIAN PHARMA PVT LTD received?

FRANCO INDIAN PHARMA 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 FRANCO INDIAN PHARMA PVT LTD come from?

All FDA import refusal data for FRANCO INDIAN PHARMA 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.