Bioreliance Ltd.

FDA Regulatory Profile

Bioreliance Ltd. has 0 FDA recalls, 35 inspections, 0 510(k) clearances and 1 compliance action on record.

What these totals cover: FDA records filed under the name "Bioreliance Ltd." and its spelling variants "Bioreliance", "Bioreliance Corporation", "Bioreliance Limited".

Latest inspection
May 13, 2026 · 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
Inspections35Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

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

Bioreliance Ltd.: FDA inspections per year 2017: 2 inspections220172018: 1 inspections120182019: 4 inspections420192020: 0 inspections020202021: 1 inspections120212022: 1 inspections120222023: 4 inspections420232024: 1 inspections120242025: 1 inspections120252026: 2 inspections22026
YearInspectionsOAIWarning lettersRecall recordsClass I
202620000
202510000
202410000
202340000
202210000
202110000
202000000
201940000
201810000
201720000

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

35 inspections from Feb 18, 2009 to May 13, 2026. Showing the 20 most recent. View all 35 inspections

DateSiteProductClassificationFEI
May 13, 2026Glasgow, United KingdomDrugsVoluntary Action Indicated (VAI)3005343934
Jan 29, 2026Rockville, MDDrugsVoluntary Action Indicated (VAI)1122041
Dec 5, 2025Glasgow, United KingdomBiologicsVoluntary Action Indicated (VAI)3005343934
Nov 22, 2024Rockville, MDBiologicsVoluntary Action Indicated (VAI)1122041
Nov 7, 2023Stirling, Scotland, United KingdomBiologicsNo Action Indicated (NAI)3005619549
Nov 7, 2023Penicuik, United KingdomBiologicsNo Action Indicated (NAI)3005619544
Nov 7, 2023Glasgow, United KingdomBiologicsNo Action Indicated (NAI)3005343934
Aug 4, 2023Rockville, MDDrugsNo Action Indicated (NAI)1122041
Jun 30, 2022Stirling, Scotland, United KingdomDrugsVoluntary Action Indicated (VAI)3005619549
Mar 17, 2021Glasgow, United KingdomDrugsVoluntary Action Indicated (VAI)3005343934
Sep 27, 2019Glasgow, United KingdomDrugsVoluntary Action Indicated (VAI)3005343934
Mar 21, 2019Stirling, Scotland, United KingdomBiologicsVoluntary Action Indicated (VAI)3005619549
Mar 21, 2019Penicuik, United KingdomBiologicsVoluntary Action Indicated (VAI)3005619544
Mar 15, 2019Glasgow, United KingdomBiologicsVoluntary Action Indicated (VAI)3005343934
Jul 13, 2018Rockville, MDDrugsVoluntary Action Indicated (VAI)1122041
Oct 10, 2017Stirling, Scotland, United KingdomDrugsVoluntary Action Indicated (VAI)3005619549
Sep 22, 2017Glasgow, United KingdomDrugsVoluntary Action Indicated (VAI)3005343934
Sep 7, 2016Penicuik, United KingdomDrugsNo Action Indicated (NAI)3005619544
Mar 17, 2016Stirling, Scotland, United KingdomBiologicsVoluntary Action Indicated (VAI)3005619549
Mar 17, 2016Penicuik, United KingdomBiologicsNo Action Indicated (NAI)3005619544
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.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Bioreliance Ltd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Jan 5, 2009.

Individual actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

4 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3005343934Glasgow, United Kingdom11May 13, 2026
FEI 1122041Rockville, MD11Jan 29, 2026
FEI 3005619544Penicuik, United Kingdom5Nov 7, 2023
FEI 3005619549Stirling, Scotland, United Kingdom8Nov 7, 2023

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