CP Pharmaceuticals Limited
⚠️ Moderate Risk
FEI: 3003369660 • Wrexham, Clwyd • UNITED KINGDOM
FEI Number
3003369660
Location
Wrexham, Clwyd
Country
UNITED KINGDOMAddress
Ash Road North, , Wrexham, Clwyd, United Kingdom
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/30/2021 | 62OCY22CARVEDILOL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/15/2018 | 66MCK36HALOPERIDOL (TRANQUILIZER) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/23/2017 | 61UCB05TAMOXIFEN CITRATE (ANTI-ESTROGEN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/28/2014 | 64RCP99HORMONE N.E.C. | Division of Southeast Imports (DSEI) | |
| 10/12/2012 | 61RDK15PROTAMINE SULFATE (ANTIDOTE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/9/2011 | 62VCA18ACYCLOVIR (ANTI-VIRAL) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/4/2007 | 54YYH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is CP Pharmaceuticals Limited's FDA import refusal history?
CP Pharmaceuticals Limited (FEI: 3003369660) has 7 FDA import refusal record(s) in our database, spanning from 6/4/2007 to 8/30/2021.
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. CP Pharmaceuticals Limited's FEI number is 3003369660.
What types of violations has CP Pharmaceuticals Limited received?
CP Pharmaceuticals Limited has been cited for 3 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 CP Pharmaceuticals Limited come from?
All FDA import refusal data for CP Pharmaceuticals Limited 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.