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PHARMCAY2U LTD

⚠️ Moderate Risk

FEI: 3007084074 • Leeds • UNITED KINGDOM

FEI

FEI Number

3007084074

📍

Location

Leeds

🇬🇧
🏢

Address

1 Hawthorn Park, , Leeds, , United Kingdom

Moderate Risk

FDA Import Risk Assessment

44.0
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
9/21/2015
Latest Refusal
5/3/2013
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
12.6×10%
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

753×

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
9/21/2015
66SCY51TADALAFIL
75UNAPPROVED
Cincinnati District Office (CIN-DO)
5/12/2014
60RAE18ORLISTAT/TETRAHYDROLIPSTATIN (ANOREXIC)
75UNAPPROVED
Philadelphia District Office (PHI-DO)
5/3/2013
65PCY02SILDENAFIL CITRATE (REGULATOR)
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is PHARMCAY2U LTD's FDA import refusal history?

PHARMCAY2U LTD (FEI: 3007084074) has 3 FDA import refusal record(s) in our database, spanning from 5/3/2013 to 9/21/2015.

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. PHARMCAY2U LTD's FEI number is 3007084074.

What types of violations has PHARMCAY2U LTD received?

PHARMCAY2U LTD 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 PHARMCAY2U LTD come from?

All FDA import refusal data for PHARMCAY2U 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.