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Macfarlan Smith Limited

FDA Regulatory Profile

Macfarlan Smith Limited has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Macfarlan Smith Limited".

Latest inspection
Nov 29, 2021 · 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
Inspections5Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

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

Macfarlan Smith Limited: FDA inspections per year 2017: 1 inspections120172018: 0 inspections020182019: 1 inspections120192020: 0 inspections020202021: 1 inspections120212022: 0 inspections020222023: 0 inspections020232024: 0 inspections020242025: 0 inspections020252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500000
202400000
202300000
202200000
202110000
202000000
201910000
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

5 inspections from Apr 13, 2012 to Nov 29, 2021.

DateSiteProductClassificationFEI
Nov 29, 2021Edinburgh, United KingdomDrugsVoluntary Action Indicated (VAI)3002807530
Jan 31, 2019Annan, United KingdomDrugsVoluntary Action Indicated (VAI)3013689380
Nov 10, 2017Edinburgh, United KingdomDrugsVoluntary Action Indicated (VAI)3002807530
Sep 4, 2015Edinburgh, United KingdomDrugsVoluntary Action Indicated (VAI)3002807530
Apr 13, 2012Edinburgh, United KingdomDrugsVoluntary Action Indicated (VAI)3002807530
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 3002807530Edinburgh, United Kingdom4Nov 29, 2021
FEI 3013689380Annan, United Kingdom1Jan 31, 2019

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FDA data resources

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