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Brookfield Medical/Surgical Supply, Inc. FDA Record

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

Latest inspection VAI · May 10, 2024
Last warning letter 2016

Inspections 4

2 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Jul 6, 2016

510(k) clearances 0 None on file

Brookfield Medical/Surgical Supply, Inc. has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Brookfield Medical/Surgical Supply, Inc., the most recent on Jul 6, 2016. FDA has published 3 Form 483s for Brookfield Medical/Surgical Supply, Inc..

What these totals cover: FDA records filed under the name "Brookfield Medical/Surgical Supply, Inc." and its spelling variant "Brookfield Medical/Surgical Supply".

Latest inspection: May 10, 2024 · 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	4	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

Brookfield Medical/Surgical Supply, Inc.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Brookfield Medical/Surgical Supply, Inc.: FDA inspections per year

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

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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Brookfield Medical/Surgical Supply, Inc. FDA Warning Letters

1 warning letter on Jul 6, 2016.

Issued	Subject	Issuing office	Close-out letter
Jul 6, 2016 · 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.

Brookfield Medical/Surgical Supply, Inc. Form 483s

3 Form 483s published by FDA.

Date	Document	FEI
Dec 21, 2018 · Document on fda.gov	483	3011430551
Sep 27, 2017 · Document on fda.gov	483	3011430551
May 24, 2017 · Document on fda.gov	483	3011430551

A Form 483 lists the observations FDA investigators made at the end of an inspection. FDA publishes some Form 483s in its reading room, and each date links to that document. Read the observations with the FDA 483 search.

Recent FDA inspections

4 inspections from Apr 9, 2015 to May 10, 2024.

Date	Site	Product	Classification	FEI
May 10, 2024	Brookfield, CT	Drugs	Voluntary Action Indicated (VAI)	3011430551
Dec 21, 2018	Brookfield, CT	Drugs	Voluntary Action Indicated (VAI)	3011430551
Apr 18, 2017	Brookfield, CT	Drugs	Official Action Indicated (OAI)	3011430551
Apr 9, 2015	Brookfield, CT	Drugs	Official Action Indicated (OAI)	3011430551

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 Brookfield Medical/Surgical Supply, Inc.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Jul 6, 2016.

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 3011430551	Brookfield, CT	4	May 10, 2024

Brookfield Medical/Surgical Supply, Inc. and the FDA: common questions

Has Brookfield Medical/Surgical Supply, Inc. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Brookfield Medical/Surgical Supply, Inc.. The most recent is dated Jul 6, 2016.

Has Brookfield Medical/Surgical Supply, Inc. received an FDA Form 483?

FDA has published 3 Form 483s for Brookfield Medical/Surgical Supply, Inc. in its reading room, the most recent dated Dec 21, 2018. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Brookfield Medical/Surgical Supply, Inc.?

The most recent FDA inspection on file ended May 10, 2024 at Brookfield, CT and was classified VAI. FDA has 4 inspections of Brookfield Medical/Surgical Supply, Inc. on file, 2 of them classified OAI (official action indicated).

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