ImportRefusal LogoImportRefusal

International Pharmacy Organsation

⚠️ Moderate Risk

FEI: 1000309874 • London • UNITED KINGDOM

FEI

FEI Number

1000309874

📍

Location

London

🇬🇧
🏢

Address

85 Station Rd Edgeware, Middlesex, London, , United Kingdom

Moderate Risk

FDA Import Risk Assessment

43.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
5/8/2002
Latest Refusal
10/18/2001
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

712×

NO LICENSE

The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use

Refusal History

DateProductViolationsDivision
5/8/2002
57DB14IMMUNE SERUM GLOBULIN (HUMAN) (BLOOD AND BLOOD DERIVATIVES)
71NO LICENSE
New Orleans District Office (NOL-DO)
10/18/2001
57DF14IMMUNE SERUM GLOBULIN (HUMAN) (BLOOD AND BLOOD DERIVATIVES)
71NO LICENSE
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is International Pharmacy Organsation's FDA import refusal history?

International Pharmacy Organsation (FEI: 1000309874) has 2 FDA import refusal record(s) in our database, spanning from 10/18/2001 to 5/8/2002.

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. International Pharmacy Organsation's FEI number is 1000309874.

What types of violations has International Pharmacy Organsation received?

International Pharmacy Organsation 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 International Pharmacy Organsation come from?

All FDA import refusal data for International Pharmacy Organsation 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.