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CP Pharmaceuticals Limited FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Latest inspection OAI · Oct 13, 2015
Last warning letter 2016

Inspections 4

2 OAI

Recalls 0 0 Class I

Warning letters 2 Latest Nov 16, 2016

510(k) clearances 0 None on file

CP Pharmaceuticals Limited has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 2 compliance actions on record. FDA has issued 2 warning letters to CP Pharmaceuticals Limited, the most recent on Nov 16, 2016.

What these totals cover: FDA records filed under the name "CP Pharmaceuticals Limited".

Latest inspection: Oct 13, 2015 · OAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	4	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	2	Nov 2, 2026	Newest record Oct 29, 2026	Current

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CP Pharmaceuticals Limited FDA Warning Letters

2 warning letters from Oct 29, 2010 to Nov 16, 2016.

Issued	Subject	Issuing office	Close-out letter
Nov 16, 2016 · Record page
Oct 29, 2010 · Record page

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent FDA inspections

4 inspections from Jul 29, 2010 to Oct 13, 2015.

Date	Site	Product	Classification	FEI
Oct 13, 2015	Wrexham, United Kingdom	Drugs	Official Action Indicated (OAI)	3003369660
Sep 10, 2013	Wrexham, United Kingdom	Drugs	Voluntary Action Indicated (VAI)	3003369660
May 13, 2011	Wrexham, United Kingdom	Drugs	Voluntary Action Indicated (VAI)	3003369660
Jul 29, 2010	Wrexham, United Kingdom	Drugs	Official Action Indicated (OAI)	3003369660

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

Compliance Actions

FDA's compliance actions data lists 2 compliance actions under CP Pharmaceuticals Limited: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Nov 16, 2016.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3003369660	Wrexham, United Kingdom	4	Oct 13, 2015

CP Pharmaceuticals Limited and the FDA: common questions

Has CP Pharmaceuticals Limited received an FDA warning letter?

Yes. FDA has issued 2 warning letters to CP Pharmaceuticals Limited. The most recent is dated Nov 16, 2016.

Has CP Pharmaceuticals Limited received an FDA Form 483?

FDA has not published a Form 483 for "CP Pharmaceuticals Limited" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect CP Pharmaceuticals Limited?

The most recent FDA inspection on file ended Oct 13, 2015 at Wrexham, United Kingdom and was classified OAI. FDA has 4 inspections of CP Pharmaceuticals Limited on file, 2 of them classified OAI (official action indicated).

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