Piramal Healthcare (Canada) Ltd. FDA Record

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

  • Latest inspection NAI · May 30, 2025
  • No warning letters matched by name
Inspections 5 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 0 None on file

Piramal Healthcare (Canada) Ltd. has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Piramal Healthcare (Canada) Ltd." is on file.

What these totals cover: FDA records filed under the name "Piramal Healthcare (Canada) Ltd." and its spelling variant "Piramal Healthcare (Canada)".

Latest inspection
May 30, 2025 · NAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections5Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

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

Piramal Healthcare (Canada) Ltd.: FDA inspections per year

YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202510000
202400000
202300000
202200000
202100000
202000000
201900000
201810000
201700000

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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Recent FDA inspections

5 inspections from Oct 17, 2008 to May 30, 2025.

DateSiteProductClassificationFEI
May 30, 2025Aurora, CanadaVeterinaryNo Action Indicated (NAI)3002808377
May 18, 2018Aurora, CanadaDrugsNo Action Indicated (NAI)3002808377
Jun 27, 2014Aurora, CanadaDrugsNo Action Indicated (NAI)3002808377
Jul 15, 2011Aurora, CanadaDrugsNo Action Indicated (NAI)3002808377
Oct 17, 2008Aurora, CanadaDrugsVoluntary Action Indicated (VAI)3002808377
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

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3002808377Aurora, Canada5May 30, 2025

Piramal Healthcare (Canada) Ltd. and the FDA: common questions

Has Piramal Healthcare (Canada) Ltd. received an FDA warning letter?

No FDA warning letter addressed to the name "Piramal Healthcare (Canada) Ltd." 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 Piramal Healthcare (Canada) Ltd. received an FDA Form 483?

FDA has not published a Form 483 for "Piramal Healthcare (Canada) Ltd." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Piramal Healthcare (Canada) Ltd.?

The most recent FDA inspection on file ended May 30, 2025 at Aurora, Canada and was classified NAI. FDA has 5 inspections of Piramal Healthcare (Canada) Ltd. on file.

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