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SPI Pharma, Inc.

⚠️ Moderate Risk

FEI: 2515692 • Lewes, DE • UNITED STATES

FEI

FEI Number

2515692

📍

Location

Lewes, DE

🇺🇸
🏢

Address

40 Cape Henlopen Dr, , Lewes, DE, United States

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
1/28/2004
Latest Refusal
1/28/2004
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

1151×

DR QUALITY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.

Refusal History

DateProductViolationsDivision
1/28/2004
60SAR04ALUMINUM HYDROXIDE (ANTACID)
115DR QUALITY
New York District Office (NYK-DO)

Frequently Asked Questions

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

SPI Pharma, Inc. (FEI: 2515692) has 1 FDA import refusal record(s) in our database, spanning from 1/28/2004 to 1/28/2004.

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 2515692.

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.