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Salem Health FDA Record

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

Salem Health has 0 FDA recalls, 9 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Salem Health" is on file.

What these totals cover: FDA records filed under the name "Salem Health".

Latest inspection: Apr 4, 2025 · NAI

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	9	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Salem Health'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	1	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	1	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	0	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.

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Recent FDA inspections

9 inspections from Jan 12, 2009 to Apr 4, 2025.

Date	Site	Product	Classification	FEI
Apr 4, 2025	Salem, OR	Biologics	No Action Indicated (NAI)	3071142
Apr 6, 2022	Salem, OR	Biologics	No Action Indicated (NAI)	3071142
Nov 21, 2017	Salem, OR	Biologics	No Action Indicated (NAI)	3071142
Apr 5, 2016	Salem, OR	Biologics	No Action Indicated (NAI)	3071142
Mar 19, 2014	Salem, OR	Biologics	No Action Indicated (NAI)	3071142
Dec 19, 2012	Salem, OR	Biologics	No Action Indicated (NAI)	3071142
Jan 23, 2012	Salem, OR	Biologics	Voluntary Action Indicated (VAI)	3071142
Sep 23, 2010	Salem, OR	Biologics	No Action Indicated (NAI)	3071142
Jan 12, 2009	Salem, OR	Biologics	Voluntary Action Indicated (VAI)	3071142

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

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3071142	Salem, OR	9	Apr 4, 2025

Salem Health and the FDA: common questions

Has Salem Health received an FDA warning letter?

No FDA warning letter addressed to the name "Salem Health" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Salem Health received an FDA Form 483?

FDA has not published a Form 483 for "Salem Health" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Salem Health?

The most recent FDA inspection on file ended Apr 4, 2025 at Salem, OR and was classified NAI. FDA has 9 inspections of Salem Health on file.

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