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Sutter Medical Center, Sacramento FDA Record

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

Sutter Medical Center, Sacramento has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Sutter Medical Center, Sacramento" is on file.

What these totals cover: FDA records filed under the name "Sutter Medical Center, Sacramento" and its spelling variant "Sutter Medical Center Sacramento".

Latest inspection: Dec 17, 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	5	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

Sutter Medical Center, Sacramento'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	0	0	0	0	0
2021	1	0	0	0	0
2020	0	0	0	0	0
2019	0	0	0	0	0
2018	0	0	0	0	0
2017	0	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

5 inspections from Sep 11, 2009 to Dec 17, 2025.

Date	Site	Product	Classification	FEI
Dec 17, 2025	Sacramento, CA	Biologics	No Action Indicated (NAI)	3000717837
Dec 3, 2021	Sacramento, CA	Biologics	No Action Indicated (NAI)	3005339885
Aug 27, 2012	Sacramento, CA	Biologics	Voluntary Action Indicated (VAI)	3005339885
Oct 27, 2009	Sacramento, CA	Biologics	No Action Indicated (NAI)	3000717837
Sep 11, 2009	Sacramento, CA	Biologics	Voluntary Action Indicated (VAI)	3005339885

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 3000717837	Sacramento, CA	2	Dec 17, 2025
FEI 3005339885	Sacramento, CA	3	Dec 3, 2021

Sutter Medical Center, Sacramento and the FDA: common questions

Has Sutter Medical Center, Sacramento received an FDA warning letter?

No FDA warning letter addressed to the name "Sutter Medical Center, Sacramento" 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 Sutter Medical Center, Sacramento received an FDA Form 483?

FDA has not published a Form 483 for "Sutter Medical Center, Sacramento" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Sutter Medical Center, Sacramento?

The most recent FDA inspection on file ended Dec 17, 2025 at Sacramento, CA and was classified NAI. FDA has 5 inspections of Sutter Medical Center, Sacramento on file.

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