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Brigham And Women's Hospital, Inc., The FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Latest inspection VAI · Jun 22, 2026
Last warning letter 2022

Inspections 6

2 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Apr 11, 2022

510(k) clearances 0 None on file

Brigham And Women's Hospital, Inc., The has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Brigham And Women's Hospital, Inc., The, the most recent on Apr 11, 2022.

What these totals cover: FDA records filed under the name "Brigham And Women's Hospital, Inc., The" and its spelling variant "Brigham And Women Hospital, Inc., The".

Latest inspection: Jun 22, 2026 · VAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 11, 2026 (checked Nov 15, 2026, unchanged)	File dated Nov 10, 2026	Current
510(k) clearances	0	Nov 15, 2026	File dated Nov 9, 2026	Current
Inspections	6	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Brigham And Women's Hospital, Inc., The's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Brigham And Women's Hospital, Inc., The: FDA inspections per year

Year	Inspections	OAI	Warning letters
2026	1	0	0
2025	0	0	0
2024	0	0	0
2023	1	0	0
2022	0	0	1
2021	1	1	0
2020	0	0	0
2019	1	1	0
2018	0	0	0
2017	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.

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Brigham And Women's Hospital, Inc., The FDA Warning Letters

1 warning letter on Apr 11, 2022.

Issued	Subject	Issuing office	Close-out letter
Apr 11, 2022 · Record page

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent FDA inspections

6 inspections from Aug 15, 2014 to Jun 22, 2026.

Date	Site	Product	Classification	FEI
Jun 22, 2026	Boston, MA	Drugs	Voluntary Action Indicated (VAI)	3012030543
Apr 11, 2023	Boston, MA	Drugs	No Action Indicated (NAI)	3012030543
Sep 16, 2021	Boston, MA	Drugs	Official Action Indicated (OAI)	3012030543
Aug 22, 2019	Boston, MA	Drugs	Official Action Indicated (OAI)	3012030543
Dec 10, 2015	Boston, MA	Devices	Voluntary Action Indicated (VAI)	3012030543
Aug 15, 2014	Boston, MA	Drugs	Voluntary Action Indicated (VAI)	3012030543

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 Brigham And Women's Hospital, Inc., The: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Apr 11, 2022.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3012030543	Boston, MA	6	Jun 22, 2026

Brigham And Women's Hospital, Inc., The and the FDA: common questions

Has Brigham And Women's Hospital, Inc., The received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Brigham And Women's Hospital, Inc., The. The most recent is dated Apr 11, 2022.

Has Brigham And Women's Hospital, Inc., The received an FDA Form 483?

FDA has not published a Form 483 for "Brigham And Women's Hospital, Inc., The" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Brigham And Women's Hospital, Inc., The?

The most recent FDA inspection on file ended Jun 22, 2026 at Boston, MA and was classified VAI. FDA has 6 inspections of Brigham And Women's Hospital, Inc., The on file, 2 of them classified OAI (official action indicated).

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