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McCallum Manufacturing Limited

FDA Regulatory Profile

McCallum Manufacturing Limited has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest inspection
Sep 15, 2023 · OAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections2Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Sep 15, 2023Barnsley, United KingdomDrugsOfficial Action Indicated (OAI)3004464535
Jul 26, 2017Barnsley, United KingdomDrugsOfficial Action Indicated (OAI)3004464535

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3004464535Barnsley, United Kingdom2Sep 15, 2023

FDA data resources

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