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Glaxo Operations U.K. Ltd.

FDA Regulatory Profile

Glaxo Operations U.K. Ltd. has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Glaxo Operations U.K. Ltd." and its spelling variant "Glaxo Operations U.K". Records filed under related names are not included; see Related names.

Latest inspection
Feb 10, 2023 · VAI

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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
Inspections8Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Glaxo Operations U.K. Ltd.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Glaxo Operations U.K. Ltd.: FDA inspections per year 2017: 1 inspections120172018: 0 inspections020182019: 0 inspections020192020: 0 inspections020202021: 0 inspections020212022: 0 inspections020222023: 1 inspections120232024: 0 inspections020242025: 0 inspections020252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500000
202400000
202310000
202200000
202100000
202000000
201900000
201800000
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.

Recent FDA inspections

8 inspections from Dec 18, 2008 to Feb 10, 2023.

DateSiteProductClassificationFEI
Feb 10, 2023Barnard Castle, United KingdomDrugsVoluntary Action Indicated (VAI)3002807078
Jun 2, 2017Barnard Castle, United KingdomDrugsVoluntary Action Indicated (VAI)3002807078
Jun 23, 2015Barnard Castle, United KingdomDrugsVoluntary Action Indicated (VAI)3002807078
May 9, 2013Barnard Castle, United KingdomDrugsVoluntary Action Indicated (VAI)3002807078
Sep 22, 2011Barnard Castle, United KingdomDrugsVoluntary Action Indicated (VAI)3002807078
Nov 1, 2010Barnard Castle, United KingdomDrugsVoluntary Action Indicated (VAI)3002807078
May 22, 2009Barnard Castle, United KingdomDrugsNo Action Indicated (NAI)3002807078
Dec 18, 2008Barnard Castle, United KingdomDrugsVoluntary Action Indicated (VAI)3002807078
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 3002807078Barnard Castle, United Kingdom8Feb 10, 2023

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FDA data resources

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