Piramal Healthcare UK Limited FDA Record

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

  • Latest inspection VAI · Mar 18, 2022
  • No warning letters matched by name
Inspections 9 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 0 None on file

Piramal Healthcare UK Limited has 0 FDA recalls, 9 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Piramal Healthcare UK Limited" is on file.

What these totals cover: FDA records filed under the name "Piramal Healthcare UK Limited" and its spelling variant "Piramal Healthcare Uk".

Latest inspection
Mar 18, 2022 · VAI

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
Inspections9Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

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

Piramal Healthcare UK Limited: FDA inspections per year

YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500000
202400000
202300000
202210000
202110000
202000000
201900000
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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Recent FDA inspections

9 inspections from Apr 9, 2009 to Mar 18, 2022.

DateSiteProductClassificationFEI
Mar 18, 2022Grangemouth, United KingdomDrugsVoluntary Action Indicated (VAI)3003723155
Jun 18, 2021Morpeth, United KingdomDrugsVoluntary Action Indicated (VAI)3002808116
Sep 21, 2018Morpeth, United KingdomDrugsVoluntary Action Indicated (VAI)3002808116
Jan 13, 2017Morpeth, United KingdomDrugsNo Action Indicated (NAI)3002808116
Jan 30, 2015Grangemouth, United KingdomDrugsVoluntary Action Indicated (VAI)3003723155
Oct 17, 2014Morpeth, United KingdomDrugsNo Action Indicated (NAI)3002808116
Jun 24, 2013Grangemouth, United KingdomDrugsVoluntary Action Indicated (VAI)3003723155
Nov 20, 2012Morpeth, United KingdomDrugsVoluntary Action Indicated (VAI)3002808116
Apr 9, 2009Morpeth, United KingdomDrugsNo Action Indicated (NAI)3002808116
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 3003723155Grangemouth, United Kingdom3Mar 18, 2022
FEI 3002808116Morpeth, United Kingdom6Jun 18, 2021

Piramal Healthcare UK Limited and the FDA: common questions

Has Piramal Healthcare UK Limited received an FDA warning letter?

No FDA warning letter addressed to the name "Piramal Healthcare UK Limited" 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 UK Limited received an FDA Form 483?

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

When did the FDA last inspect Piramal Healthcare UK Limited?

The most recent FDA inspection on file ended Mar 18, 2022 at Grangemouth, United Kingdom and was classified VAI. FDA has 9 inspections of Piramal Healthcare UK Limited on file.

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