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Brookfield Medical/Surgical Supplies, Inc. FDA Inspection Record

FEI 3011430551 · Inspections, Form 483s, warning letters and import refusals

Brookfield Medical/Surgical Supplies, Inc. is an FDA-inspected facility (FEI 3011430551) located in Brookfield, CT, US. RegDataLab tracks 4 FDA inspections and 1 compliance action at this facility.

What FDA found at this site

Latest inspection: May 10, 2024: Voluntary Action Indicated (VAI)
Inspections on record: 4 (2 OAI, 2 VAI)
Last OAI inspection: Apr 18, 2017
Warning letters: 1 listed by FDA for this FEI, latest Jul 6, 2016
Form 483 and inspection documents: 9 in FDA's reading room

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

Date	Result	What FDA cited
May 10, 2024	Voluntary Action Indicated (VAI)	Written procedures not established/followed (21 CFR 211.67(b)) Absence of Written Procedures (21 CFR 211.100(a)) Procedures for sterile drug products (21 CFR 211.113(b)) Drug product container, fails to include (FDCA 503B(a)(10)(B))
Dec 21, 2018	Voluntary Action Indicated (VAI)	Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a)) Absence of Written Procedures (21 CFR 211.100(a)) Environmental Monitoring System (21 CFR 211.42(c)(10)(iv)) Cleaning System (21 CFR 211.42(c)(10)(v)) and 2 more
Apr 18, 2017	Official Action Indicated (OAI)	SOPs not followed / documented (21 CFR 211.100(b)) Cleaning System (21 CFR 211.42(c)(10)(v)) Procedures for sterile drug products (21 CFR 211.113(b)) Investigations of discrepancies, failures (21 CFR 211.192)
Apr 9, 2015	Official Action Indicated (OAI)	Procedures not in writing, fully followed (21 CFR 211.22(d)) Cleaning System (21 CFR 211.42(c)(10)(v)) Establishment of time limitations (21 CFR 211.111) Procedures for sterile drug products (21 CFR 211.113(b)) and 3 more

Form 483s and inspection documents

483 on FDA.gov
Inspection Jun 29, 2026 to Jul 10, 2026, issued Jul 10, 2026 (dates printed on the document). FDA listing date Jul 10, 2026. Published by FDA Sep 10, 2026.
Untitled Letter on FDA.gov
FDA listing date Sep 27, 2024, which is not always the inspection or issue date. Published by FDA Nov 6, 2024.
483 on FDA.gov
Inspection Apr 22, 2024 to May 10, 2024, issued May 10, 2024 (dates printed on the document). FDA listing date May 10, 2024. Published by FDA Jun 28, 2024.
483 on FDA.gov
Inspection Mar 21, 2022 to Apr 4, 2022, issued Apr 4, 2022 (dates printed on the document). FDA listing date Apr 4, 2022. Published by FDA Sep 22, 2022.
483 on FDA.gov
Inspection Dec 10, 2018 to Dec 21, 2018, issued Dec 21, 2018 (dates printed on the document). FDA listing date Dec 21, 2018. Published by FDA Apr 30, 2019.
483 on FDA.gov
Issued Jun 28, 2017 (dates printed on the document). FDA listing date Aug 3, 2017. Published by FDA Jan 18, 2024.
483 on FDA.gov
Inspection Apr 6, 2017 to Apr 18, 2017, issued Apr 18, 2017 (dates printed on the document). FDA listing date Sep 27, 2017. Published by FDA Jan 18, 2024.
483 on FDA.gov
Inspection Apr 6, 2017 to Apr 18, 2017, issued Apr 18, 2017 (dates printed on the document). FDA listing date May 24, 2017. Published by FDA Jan 18, 2024.
483 on FDA.gov
Issued Apr 9, 2015 (dates printed on the document). FDA listing date Jul 17, 2015. Published by FDA Jan 18, 2024.

FDA record score

13 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 15, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

5 records behind this number

Record	Date	Points x age weight	Adds
Inspection classified OAI	Apr 18, 2017	30 x 0.25	7.5
Inspection classified VAI	May 10, 2024	6 x 0.6	3.6
Inspection classified VAI	Dec 21, 2018	6 x 0.25	1.5
Warning letter on FDA's dashboard, which does not show close-outs	Jul 6, 2016	10 years or older, so it adds no points	0
Inspection classified OAI	Apr 9, 2015	10 years or older, so it adds no points	0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
Records	Last refreshed	Source as of	Status
Inspections	Nov 15, 2026	Newest record Nov 5, 2026	Current
Inspection citations	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions (warning letters, injunctions and other action types)	Nov 2, 2026	Newest record Oct 29, 2026	Current
Warning letter text	Nov 14, 2026	Newest record Nov 10, 2026	Current
Recalls (Enforcement Report)	Nov 15, 2026	Newest record Nov 11, 2026	Current
Form 483s and inspection documents	Nov 13, 2026	Newest record Nov 12, 2026	Current
Import refusals	Nov 15, 2026	Newest record Nov 5, 2026	Current

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Facility details

Company: Brookfield Medical/Surgical Supply, Inc.
Location: Brookfield, CT (US)
Source: inspections