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SPI Pharma, Inc.

⚠️ Moderate Risk

FEI: 3005656135 • Bangalore, Karnataka • INDIA

FEI

FEI Number

3005656135

📍

Location

Bangalore, Karnataka

🇮🇳

Country

INDIA
🏢

Address

21B, Veerasandra Industrial Area, Anekai Taluk, Hosur Road, Bangalore, Karnataka, 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
9/1/2006
Latest Refusal
9/1/2006
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
9/1/2006
60SAN14MAGNESIUM HYDROXIDE (ANTACID)
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is SPI Pharma, Inc.'s FDA import refusal history?

SPI Pharma, Inc. (FEI: 3005656135) has 1 FDA import refusal record(s) in our database, spanning from 9/1/2006 to 9/1/2006.

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. SPI Pharma, Inc.'s FEI number is 3005656135.

What types of violations has SPI Pharma, Inc. received?

SPI Pharma, Inc. 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 SPI Pharma, Inc. come from?

All FDA import refusal data for SPI Pharma, Inc. 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.