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CP Pharmaceuticals Limited FDA Inspection Record

FEI 3003369660 · Inspections, Form 483s, warning letters and import refusals

CP Pharmaceuticals Limited is an FDA-inspected facility (FEI 3003369660) located in Wrexham, GB. RegDataLab tracks 4 FDA inspections and 2 compliance actions at this facility.

What FDA found at this site

Latest inspection
Oct 13, 2015: Official Action Indicated (OAI)
Inspections on record
4 (2 OAI, 2 VAI)
Last OAI inspection
Oct 13, 2015
Warning letters
2 listed by FDA for this FEI, latest Nov 16, 2016
Form 483 and inspection documents
1 in FDA's reading room
Import refusals
7

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Oct 13, 2015Official Action Indicated (OAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
Training , Education , Experience overall (21 CFR 211.25(a))
Equipment Design, Size and Location (21 CFR 211.63)
Absence of Written Procedures (21 CFR 211.100(a))
and 8 more
Sep 10, 2013Voluntary Action Indicated (VAI)No citations listed
May 13, 2011Voluntary Action Indicated (VAI)No citations listed
Jul 29, 2010Official Action Indicated (OAI)No citations listed

Form 483s and inspection documents

  • 483 on FDA.gov
    FDA listing date Oct 13, 2015, which is not always the inspection or issue date. Published by FDA Jan 27, 2017.

FDA record score

8 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 15, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

6 records behind this number
RecordDatePoints x age weightAdds
Warning letter on FDA's dashboard, which does not show close-outsNov 16, 201630 x 0.257.5
Inspection classified OAIOct 13, 201510 years or older, so it adds no points0
Inspection classified VAISep 10, 201310 years or older, so it adds no points0
Inspection classified VAIMay 13, 201110 years or older, so it adds no points0
Warning letter on FDA's dashboard, which does not show close-outsOct 29, 201010 years or older, so it adds no points0
Inspection classified OAIJul 29, 201010 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
CP Pharmaceuticals Limited
Location
Wrexham (GB)
Source
inspections

Compliance actions

Import refusals

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.