Contract Pharmaceuticals Limited Canada FDA Record

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

Contract Pharmaceuticals Limited Canada has 3 FDA recalls, 9 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Contract Pharmaceuticals Limited Canada" is on file. FDA has published 1 Form 483 for Contract Pharmaceuticals Limited Canada.

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

Latest recall
D-0365-2024 · Class III · Feb 20, 2024
Latest inspection
Nov 3, 2023 · VAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls3Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections9Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Contract Pharmaceuticals Limited Canada's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Contract Pharmaceuticals Limited Canada: FDA inspections per year 2017: 1 inspections120172018: 1 inspections120182019: 1 inspections120192020: 0 inspections020202021: 0 inspections020212022: 0 inspections020222023: 2 inspections220232024: 0 inspections020242025: 0 inspections020252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500000
202400020
202320010
202200000
202100000
202000000
201910000
201810000
201710000

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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Contract Pharmaceuticals Limited Canada Form 483s

1 Form 483 published by FDA.

DateDocumentFEI
Nov 3, 20234833001581899

A Form 483 lists the observations FDA investigators made at the end of an inspection. FDA publishes some Form 483s in its reading room, and each date links to that document. Read the observations with the FDA 483 search.

Recent recalls

3 recall records from Aug 23, 2023 to Feb 20, 2024.

NumberClassProductDate
D-0365-2024Class IIIClindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Manufactured for: Glasshouse…Feb 20, 2024
D-0364-2024Class IIIClindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed…Feb 20, 2024
D-1139-2023Class IIIClindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Rx only, Manufactured by: Contract…Aug 23, 2023

Recent FDA inspections

9 inspections from Sep 3, 2009 to Nov 3, 2023.

DateSiteProductClassificationFEI
Nov 3, 2023Mississauga, CanadaDrugsVoluntary Action Indicated (VAI)3001581899
Sep 13, 2023Mississauga, CanadaDrugsVoluntary Action Indicated (VAI)3011158222
May 17, 2019Mississauga, CanadaDrugsVoluntary Action Indicated (VAI)3001581899
Aug 17, 2018Mississauga, CanadaDrugsNo Action Indicated (NAI)3011158222
Mar 31, 2017Mississauga, CanadaDrugsNo Action Indicated (NAI)3001581899
Jul 14, 2015Mississauga, CanadaDrugsNo Action Indicated (NAI)3011158222
Apr 11, 2014Mississauga, CanadaDrugsVoluntary Action Indicated (VAI)3001581899
Feb 24, 2012Mississauga, CanadaDrugsVoluntary Action Indicated (VAI)3001581899
Sep 3, 2009Mississauga, CanadaDrugsNo Action Indicated (NAI)3001581899
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.

FDA-inspected facilities

2 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3001581899Mississauga, Canada6Nov 3, 2023
FEI 3011158222Mississauga, Canada3Sep 13, 2023

Contract Pharmaceuticals Limited Canada and the FDA: common questions

Has Contract Pharmaceuticals Limited Canada received an FDA warning letter?

No FDA warning letter addressed to the name "Contract Pharmaceuticals Limited Canada" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Contract Pharmaceuticals Limited Canada received an FDA Form 483?

FDA has published 1 Form 483 for Contract Pharmaceuticals Limited Canada in its reading room, the most recent dated Nov 3, 2023. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Contract Pharmaceuticals Limited Canada?

The most recent FDA inspection on file ended Nov 3, 2023 at Mississauga, Canada and was classified VAI. FDA has 9 inspections of Contract Pharmaceuticals Limited Canada on file.

Has Contract Pharmaceuticals Limited Canada had an FDA recall?

Yes. Contract Pharmaceuticals Limited Canada has 3 FDA recalls on record. The most recent started Feb 20, 2024.

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