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Children's Hospital And Research Center At Oakland FDA Record

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

Latest inspection VAI · Mar 20, 2025
No warning letters matched by name

Inspections 8

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

Children's Hospital And Research Center At Oakland has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Children's Hospital And Research Center At Oakland" is on file.

What these totals cover: FDA records filed under the name "Children's Hospital And Research Center At Oakland" and its spelling variant "Children Hospital And Research Center At Oakland".

Latest inspection: Mar 20, 2025 · 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	8	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Children's Hospital And Research Center At Oakland's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Children's Hospital And Research Center At Oakland: 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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Recent FDA inspections

8 inspections from Jun 18, 2009 to Mar 20, 2025.

Date	Site	Product	Classification	FEI
Mar 20, 2025	Oakland, CA	Biologics	Voluntary Action Indicated (VAI)	2971437
May 25, 2022	Oakland, CA	Biologics	No Action Indicated (NAI)	2971437
Sep 12, 2017	Oakland, CA	Biologics	Voluntary Action Indicated (VAI)	2971437
Mar 18, 2015	Oakland, CA	Biologics	No Action Indicated (NAI)	2971437
Jan 9, 2013	Oakland, CA	Biologics	Voluntary Action Indicated (VAI)	2971437
Mar 14, 2011	Oakland, CA	Biologics	Voluntary Action Indicated (VAI)	2971437
Sep 16, 2009	Oakland, CA	Biologics	No Action Indicated (NAI)	2971437
Jun 18, 2009	Oakland, CA	Biologics	No Action Indicated (NAI)	2971437

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 2971437	Oakland, CA	8	Mar 20, 2025

Children's Hospital And Research Center At Oakland and the FDA: common questions

Has Children's Hospital And Research Center At Oakland received an FDA warning letter?

No FDA warning letter addressed to the name "Children's Hospital And Research Center At Oakland" 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 Children's Hospital And Research Center At Oakland received an FDA Form 483?

FDA has not published a Form 483 for "Children's Hospital And Research Center At Oakland" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Children's Hospital And Research Center At Oakland?

The most recent FDA inspection on file ended Mar 20, 2025 at Oakland, CA and was classified VAI. FDA has 8 inspections of Children's Hospital And Research Center At Oakland on file.

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