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BWXT Medical Ltd.

FDA Regulatory Profile

BWXT Medical Ltd. has 0 FDA recalls, 14 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "BWXT Medical Ltd." and its spelling variant "Bwxt Medical".

Latest inspection: Feb 23, 2024 · VAI

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Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	14	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

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

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	0	0	0	0	0
2024	1	0	0	0	0
2023	2	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	1	0	0	0	0
2018	0	0	0	0	0
2017	1	0	0	0	0

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

14 inspections from Oct 23, 2008 to Feb 23, 2024.

Date	Site	Product	Classification	FEI
Feb 23, 2024	Vancouver, Canada	Drugs	Voluntary Action Indicated (VAI)	3004005970
Mar 3, 2023	Ottawa, Canada	Drugs	Voluntary Action Indicated (VAI)	3001092088
Mar 2, 2023	Ottawa, Canada	Devices	No Action Indicated (NAI)	3001092088
Jun 7, 2019	Ottawa, Canada	Drugs	No Action Indicated (NAI)	3001092088
Sep 22, 2017	Vancouver, Canada	Drugs	Voluntary Action Indicated (VAI)	3004005970
Dec 6, 2016	Ottawa, Canada	Drugs	Voluntary Action Indicated (VAI)	3001092088
Nov 7, 2014	Ottawa, Canada	Drugs	Voluntary Action Indicated (VAI)	3001092088
Sep 12, 2014	Vancouver, Canada	Drugs	Voluntary Action Indicated (VAI)	3004005970
Apr 4, 2012	Ottawa, Canada	Drugs	Voluntary Action Indicated (VAI)	3001092088
Aug 31, 2011	Ottawa, Canada	Drugs	Voluntary Action Indicated (VAI)	3001092088
Aug 18, 2011	Vancouver, Canada	Drugs	Voluntary Action Indicated (VAI)	3004005970
Aug 11, 2010	Vancouver, Canada	Drugs	No Action Indicated (NAI)	3004005970
Jun 30, 2009	Ottawa, Canada	Drugs	Voluntary Action Indicated (VAI)	3001092088
Oct 23, 2008	Ottawa, Canada	Drugs	Voluntary Action Indicated (VAI)	3001092088

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.

Facility	Location	Inspections	Latest
FEI 3004005970	Vancouver, Canada	5	Feb 23, 2024
FEI 3001092088	Ottawa, Canada	9	Mar 3, 2023

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