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Phenomena Ltd

⚠️ Moderate Risk

FEI: 3011701395 • Blandford Forum, Dorset • UNITED KINGDOM

FEI

FEI Number

3011701395

📍

Location

Blandford Forum, Dorset

🇬🇧
🏢

Address

Sutton Waldron House, , Blandford Forum, Dorset, United Kingdom

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
10/9/2015
Latest Refusal
10/9/2015
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

4721×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

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
10/9/2015
62GRP99ANTI-INFLAMMATORY N.E.C.
472NO ENGLISH
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Phenomena Ltd's FDA import refusal history?

Phenomena Ltd (FEI: 3011701395) has 1 FDA import refusal record(s) in our database, spanning from 10/9/2015 to 10/9/2015.

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. Phenomena Ltd's FEI number is 3011701395.

What types of violations has Phenomena Ltd received?

Phenomena Ltd 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 Phenomena Ltd come from?

All FDA import refusal data for Phenomena 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.