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Ubichem Plc

⚠️ Moderate Risk

FEI: 3000591288 • Hampshire • UNITED KINGDOM

FEI

FEI Number

3000591288

📍

Location

Hampshire

🇬🇧
🏢

Address

Mayflower Close, Chandlers Ford, Hampshire, , United Kingdom

Moderate Risk

FDA Import Risk Assessment

38.9
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
10/22/2004
Latest Refusal
8/4/2003
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
16.4×10%
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

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

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
10/22/2004
66VIS99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
New York District Office (NYK-DO)
8/4/2003
56AYY99PENICILLIN NATURAL, N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Ubichem Plc's FDA import refusal history?

Ubichem Plc (FEI: 3000591288) has 2 FDA import refusal record(s) in our database, spanning from 8/4/2003 to 10/22/2004.

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. Ubichem Plc's FEI number is 3000591288.

What types of violations has Ubichem Plc received?

Ubichem Plc has been cited for 2 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 Ubichem Plc come from?

All FDA import refusal data for Ubichem Plc 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.