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Ascension Saint John Medical Center FDA Record

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

Latest inspection VAI · May 9, 2025
No warning letters matched by name

Inspections 7

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

Ascension Saint John Medical Center has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Ascension Saint John Medical Center" is on file. FDA has published 1 Form 483 for Ascension Saint John Medical Center.

What these totals cover: FDA records filed under the name "Ascension Saint John Medical Center".

Latest inspection: May 9, 2025 · VAI

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	7	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

Ascension Saint John Medical Center's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Ascension Saint John Medical Center: FDA inspections per year

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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Ascension Saint John Medical Center Form 483s

1 Form 483 published by FDA.

Date	Document	FEI
May 9, 2025 · Document on fda.gov	483	1671035

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

7 inspections from Dec 4, 2009 to May 9, 2025.

Date	Site	Product	Classification	FEI
May 9, 2025	Tulsa, OK	Biologics	Voluntary Action Indicated (VAI)	1671035
Jul 19, 2022	Tulsa, OK	Biologics	No Action Indicated (NAI)	1671035
Dec 1, 2017	Tulsa, OK	Biologics	Voluntary Action Indicated (VAI)	1671035
Mar 11, 2016	Tulsa, OK	Biologics	No Action Indicated (NAI)	1671035
Mar 4, 2014	Tulsa, OK	Biologics	Voluntary Action Indicated (VAI)	1671035
Feb 14, 2012	Tulsa, OK	Biologics	No Action Indicated (NAI)	1671035
Dec 4, 2009	Tulsa, OK	Biologics	Voluntary Action Indicated (VAI)	1671035

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 1671035	Tulsa, OK	7	May 9, 2025

Ascension Saint John Medical Center and the FDA: common questions

Has Ascension Saint John Medical Center received an FDA warning letter?

No FDA warning letter addressed to the name "Ascension Saint John Medical Center" 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 Ascension Saint John Medical Center received an FDA Form 483?

FDA has published 1 Form 483 for Ascension Saint John Medical Center in its reading room, the most recent dated May 9, 2025. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Ascension Saint John Medical Center?

The most recent FDA inspection on file ended May 9, 2025 at Tulsa, OK and was classified VAI. FDA has 7 inspections of Ascension Saint John Medical Center on file.

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